Principal Regulatory Affairs Specialist - Diabetes Care (on-site)
$100k - $200kAbbott Laboratories
- # Principle Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations: United States - California - Alamedatime type: Full timeposted on: Posted Todayjob requisition id: 31151822Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.## **JOB DESCRIPTION:****Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:* Career development with an international company where you can grow the career you dream of.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year* An excellent retirement savings plan with high employer contribution* Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.**The Opportunity**The **Principal RA Specialist** will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs.Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. The individual has department level influence with experience in US submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.**What You’ll Work On*** Develop global regulatory strategies for product development and planning throughout the product lifecycle.* Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.* Provide technical leadership and strategic input on complex issues and to business units.* Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.* Work on Sustaining Activities.* Create project plans and timelines.* Lead functional groups in the development of relevant data to complete a regulatory submission.* Write and edit technical documents.* Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.* Negotiate with regulatory authorities during the development and review process to ensure submission approval.* Review and approve labeling to ensure compliance.* Monitor emerging issues and identify solutions.* Negotiate internally and externally with regulatory agencies.* Evaluate regulatory risks of corporate policies.* Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.* Ensure compliance with product post-marketing approval requirements.* Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.* Actively contribute to the development and functioning of the crisis/issue management program* Analyze product-associated problems and develop proposals for solutions.* Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.* Provide regulatory input for product recalls and recall communications.**Required Qualifications*** Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)* Experienced in regulatory submissions for Combination Devices, In Vitro Diagnostic Devices and/or Medical Devices.* Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).**Preferred Qualifications*** 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.* Experience with either 510(k) applications, PMA supplements, US Device regulations, or with EU and other international medical device regulations and submissions.* Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines.* Experience with word processing, spreadsheet and presentation graphic software packages.* Experience working in a broader enterprise/cross-division business unit model.* Ability to work in a highly matrixed and geographically diverse business environment.* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.* Ability to leverage and/or engage others to accomplish projects.* Ability to identify, solve problems, and work independently with little oversight.* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.* Multitasks, prioritizes, and meets deadlines in a timely manner.* Strong organizational and follow-up skills, as well as attention to detail* Ability to travel approximately 5%, including international travel.**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.**The base pay for this position is**$100,000.00 – $200,000.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Regulatory Operations## **DIVISION:**ADC Diabetes Care## **LOCATION:**United States > Alameda : 2901 Harbor Bay Parkway## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Yes, 5 % of the Time## **MEDICAL SURVEILLANCE:**No## **SIGNIFICANT WORK ACTIVITIES:**Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol:
- J-18808-Ljbffr Abbott Laboratories
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Principal Regulatory Affairs Specialist - Diabetes Care (on-site) in Alameda, CA vacancy
$100k - $200k
...work that matters, grow, and learn, care for yourself and family, be your true... ...scientists. The Opportunity This Principal Regulatory Affairs Specialist - APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping...PrincipalDiabetesWebsiteFor contractors$100k - $200k
...matters, grow, and learn, care for yourself and... ...believe people with diabetes should have the freedom... ...Opportunity This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA... ...from the Regulatory Affairs Professionals Society...PrincipalDiabetesWebsiteFull timeWorldwide$100k - $200k
Job Overview The Principal RA Specialist works on-site at Abbott's facility in Alameda, CA in the Diabetes Care Division, focusing on U.S. regulatory submissions for new product introductions and sustaining... .../or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus....DiabetesWebsiteShift work$148.7k - $297.3k
The Opportunity This Associate Director Regulatory Affairs will work on‑site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life‑changing products that provide accurate data to drive...DiabetesWebsite$85k
...a physical Medtronic site, the candidate hired will... ...in the Life As a Principal Territory Manager for... ...Leadership, clinical specialists, and inventory analysts... ...from heart disease to diabetes. Our industry leadership... .... Insight-driven care . Fresh viewpoints. Cutting...PrincipalDiabetesWebsiteContract workH1bWork at officeLocal areaRemote workFlexible hoursShift workNight shiftMedtronic
Oakland, CA1 day ago$120k
...at a physical Medtronic site, the candidate hired... ...find all CRDN Clinical Specialist roles available please... ...offered exclusively for Principal-level roles and above,... ...from heart disease to diabetes. Our industry leadership... ...walls. Insight-driven care . Fresh viewpoints. Cutting...PrincipalDiabetesWebsiteH1bWork at officeLocal areaImmediate startRemote workFlexible hoursMedtronic
Oakland, CA2 days ago- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist in Alameda, CA. This role involves leading regulatory submissions for diabetes care technologies, ensuring compliance with US and EU regulations, and interacting with regulatory agencies. The ideal...PrincipalDiabetes
- Abbott in Alameda, CA is seeking a Principal RA Specialist to lead regulatory submissions in diabetes care. This role focuses on advancing diabetes management technologies and requires expertise in regulatory compliance. The position necessitates a Bachelor's degree in...Diabetes
$90k - $180k
## Senior Regulatory Affairs Specialist - Lingo (on-site)Candidatar-selocations: United States - California - Alamedatime type: Tempo Integralposted on: Publicado... ..., you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a...Website$114k - $228k
...that matters, grow, and learn, care for yourself and your family,... ...Alameda, CA location in the Abbott Diabetes Care Division, where we are... .... This is a fully on‑site role in our main Alameda, CA site... ...market trends, consumer behaviors, regulatory environments, and competitive...DiabetesWebsiteWork at officeWorldwide$73.9k - $116k
...matters, grow, and learn, care for yourself and your... ...ISO14155.This is an on-site position in Alameda,... ..., and other applicable regulatory requirements.* Participate... ...and Regulatory Affairs* Flexibility in daily activities... ...500,000 people with diabetes from routine fingersticks...DiabetesWebsiteInterim roleWorldwide$114k - $228k
This position works out of our Alameda, CA location in the Diabetes Care division where we’re focused on helping people with diabetes manage... ...Planning & Optimization Partner with Supply Planning and site leadership to support integrated business planning. Ensure optimal...DiabetesWebsiteLong term contractContract workTemporary workWork experience placement$114k - $228k
...that matters, grow, and learn, care for yourself and family, be... ...Abbott, we believe people with diabetes should have the freedom to... ...technology.**The Opportunity**This **Regulatory Affairs Manager - International... ...Operations** will work on-site at our Alameda, CA location in...DiabetesWebsiteFor contractorsWork experience placementWorldwide- ...regardless of regular schedule and may include multiple sites* | Required Exp: One-year Locums experience... ...managing routine checkups, chronic conditions (e.g., diabetes, hypertension), and preventive care. Providers must be able to see Newborns to Geriatric patients...DiabetesWebsiteLocumShift work
ERO Locums
Alameda, CA2 hours ago $325.2k - $345.9k
...About Us One Medical is a primary care solution challenging the industry status quo... ...and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic... ...primary care issues (e.g., hypertension, diabetes, depression/anxiety) Complete thorough...DiabetesWebsiteFull timeTemporary workWork at officeRelocation packageFlexible hoursShift workAfternoon shift$100k - $200k
Abbott Laboratories in Alameda, CA, is seeking a Principal RA Specialist to oversee U.S. regulatory submissions. The role involves developing global regulatory strategies, providing technical leadership, and ensuring compliance with regulatory requirements. The ideal candidate...PrincipalDiabetes$135k - $200k
...technical expertise and keen awareness of the regulatory framework to achieve our clients'... ...environmental consulting firm seeking a Principal Environmental Compliance Consultant (Scientist... ...Service Areas—alongside Environmental, Site Engineering, and Water Resources. The...PrincipalWebsiteContract workFor subcontractorLocal areaFlexible hoursTerraphase Engineering Inc
Oakland, CA24 days ago$2,400 - $10,000 per month
...current health status, gaps in care, potential health risks and... ...Practice Standards: American Diabetes Association (ADA), American College... ...or Clinical Nurse Specialist in Family, Adult, Gerontology... ...soundclinical decisions without direct on-site supervision Proficient with...DiabetesWebsiteDaily paidLocal areaRemote workComplexCare Solutions
Oakland, CA5 days ago$90k
...next level by joining a global medical device market leader in diabetes care? At Insulet Corporation, we are transforming lives with... ...position is filled. To apply, please visit the Insulet Careers site and submit your application online. NOTE: This position...DiabetesWebsiteWork at officeLocal areaRemote workNight shiftInsulet Corporation
Berkeley, CA3 days ago- ...II (CM II), a key member of the primary care interdisciplinary team, provides services... ...appropriate or required by the specific program/site. The CM II provides services to specific... ...Hep C, congestive heart failure, severe diabetes, severe hypertension, psychosis,...DiabetesWebsiteWork at officeFlexible hours
LifeLong Medical Care
Oakland, CA3 days ago - ...III (CM III), a key member of the primary care interdisciplinary team, provides services... ...or required by the specific program/site. The CM III provides services to specific... ...Hep C, congestive heart failure, severe diabetes, severe hypertension, psychosis, pregnancy...DiabetesWebsiteTemporary workWork at officeLocal areaFlexible hours
LifeLong Medical Care
Oakland, CA2 days ago $90k
...next level by joining a global medical device market leader in diabetes care? At Insulet Corporation, we are transforming lives with... ...position is filled. To apply, please visit the Insulet Careers site and submit your application online./ppNOTE: This position requires...DiabetesWebsiteWork at officeLocal areaRemote workNight shift$114k - $228k
...position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people manage their... ...objectives. #software #embedded #CI/CD This is a fully on-site role in Alameda, CA What you’ll work on Self-starter that...DiabetesWebsiteFull time$138.2k - $228k
...for students, faculty and staff. Senior Principal Researcher, Health Informatics & Digital... ...integrated into real‑world clinical and community-care ecosystems. Provides authoritative... ...integration. Directs multi-year, multi-site digital health projects involving health...PrincipalWebsiteHourly payContract workTemporary workRemote work$203.65k - $225.12k
...rewarding and meaningful. LifeLong Medical Care is looking for a Physician or Advanced... ...fill a part-time position across multiple sites in its Homeless Services Department. Please... ...services, women's health, house calls, diabetes, Bridge, etc.) Coordinates care with...DiabetesWebsitePermanent employmentFull timePart timeRelocation packageFlexible hoursLifeLong Medical Care
Berkeley, CA5 days ago$90k - $180k
A global healthcare leader in California is seeking a skilled professional for an onsite role in its Diabetes Care Division. This position involves managing warranty orders, monitoring inventory, and addressing customer inquiries. The ideal candidate should have an associate...Diabetes$90k - $180k
A global healthcare leader is seeking an individual for an onsite position in their Diabetes Care Division in Alameda. The role involves maintaining warranty orders in SAP, monitoring inventory, and responding to customer inquiries. Candidates must have an associate degree...Diabetes$38.37 - $56.17 per hour
..., implementing and evaluating care of patients. The staff RN utilizes... .... Follow hospital, regulatory and professional guidelines, policies... ...unit(the biggest in the care site) that specializes in caring... ...multiple diagnoses including sepsis, diabetes, electrolyte imbalances,...DiabetesWebsiteHourly payFull timeWork at officeLocal areaShift workNight shiftWeekend workAfternoon shiftIntermountain Health
Oakland, CA10 hours ago- ...is looking for a Senior Embedded Software Engineer to work on embedded product software within the Abbott Diabetes Care Division in Alameda, CA. This fully on-site position involves developing and maintaining high-quality embedded software and CI/CD pipelines, leading technical...DiabetesWebsite
- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for its Diabetes Care Division in Alameda, California. This role involves developing regulatory strategies for innovative diabetes management products and ensuring compliance with industry standards...Diabetes
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Regulatory Affairs Specialist - Diabetes Care (on-site). Be the first to apply!
Related searches
- regulatory officer Alameda, CA
- compliance consultant Alameda, CA
- healthcare compliance officer Alameda, CA
- regulatory affairs consultant Alameda, CA
- regulatory compliance specialist Alameda, CA
- risk and compliance analyst Alameda, CA
- aml compliance analyst Alameda, CA
- compliance officer Alameda, CA
- compliance coordinator Alameda, CA
- research compliance officer Alameda, CA