Sr. Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences
Responsibilities:
- Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Assist in SOP development and review in support of "next-gen " product offerings.
- Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.
- Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for Client products
- Assist in preparation and review of regulatory submission to authorities.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individuals may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
- Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of client products and product changes.
- Ensuring timely submission of adverse events to the appropriate regulatory bodies.
- Bachelor's degree in relevant field (or equivalent experience)
- 6 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred).
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred.
- Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.
- Experience interacting with OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections and US.
- Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
- Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
- Excellent written and oral communication skills
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Sr. Regulatory Affairs Specialist in Irvine, CA vacancy
- ...Regulatory Affairs Specialist Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices...Senior
Katalyst HealthCares & Life Sciences
Irvine, CA3 days ago - ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...SeniorWork at officeLocal area3 days per week
Intracept by Boston Scientific
Irvine, CA1 day ago $85k - $130k
Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products...SeniorWork experience placementLocal areaWorldwideFlexible hours- ...Principal Regulatory Affairs Specialist Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed...SuggestedWork at officeRemote work
Diality
Irvine, CA5 days ago - UCI Health seeks an experienced credentialing professional to perform a full range of responsibilities within credentialing practices. The role supports Medical Staff bylaws, state and federal laws, and NCQA standards, coordinating meetings and reports while ensuring licensure...Senior
University Of California Irvine
Irvine, CA3 days ago $95.8k - $159.6k
...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product...SeniorFull timeLocal areaStryker
Irvine, CA23 days ago- ...policies, processes, and resources. The Senior Credentialing Specialist serves as an essential link and resource between department senior... ...compliance with organizational policies and accrediting and regulatory standards. Responsible for meeting management to the...SeniorMonday to Friday
University Of California Irvine
Irvine, CA1 day ago $60 per hour
...Take your regulatory affairs expertise to the next level with an opportunity to support innovative diagnostic products on a global scale.... ...0 PM Why This Role Matters As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic products meet...Hourly payTemporary workMonday to FridayManpower
Irvine, CA1 day ago- ...Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S... ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems...Work at office
Katalyst Healthcares and Life Sciences
Irvine, CA5 days ago - ...medical technology or similar. ~5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the... ...and written communication skills. ~ Thorough knowledge of policies, practices and procedures related to Regulatory Affairs....
Katalyst HealthCares & Life Sciences
Irvine, CA2 days ago $85.8k - $137.3k
...demand reports and SKU lists for Compliance Specialists and ManagementReview and upload approved... ...data as requested by Supervisor or Sr. ManagementManage Vendor classification... ...SupervisorAdministrative support for required regulatory reporting requirements in a timely...SeniorFull timeTemporary workImmediate startWorldwideFlexible hours$99.7k - $152.08k
The Sr. Export Compliance Specialist supports the company’s export compliance program to ensure compliance with U.S. export control regulations and protect sensitive technology and information. This role partners cross-functionally to provide practical compliance guidance...SeniorPermanent employmentFull timeFor contractorsCasual workWork at office$143k - $286.4k
...Job Description Apply now Job Title: Sr. Principal Systems Engineer Posting Start Date: 7/27/26 Job... ...collaborate with many teams, including multiple R&D, product, and regulatory groups. You will work in a fast-paced, results oriented environment...SeniorSkyworks Solutions
Irvine, CA2 days ago$110.1k - $183.4k
...Staff International Regulatory Affairs Specialist In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful opportunity to drive operational...Local areaStryker
Irvine, CA2 days ago$76k - $121.9k
...dignity of our employees and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category... ...Description Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular. At Johnson & Johnson,we believe...Temporary workLocal area$143k - $286.4k
If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high-performance analog semiconductors whose solutions are powering the wireless networking revolution. Through our broad technology expertise...SeniorSkyworks
Irvine, CAmore than 2 months ago- Anduril Industries in Costa Mesa, CA is seeking an experienced Information Systems Security Manager to lead security controls, risk assessments, and continuous monitoring across classified deployments. You’ll work with program teams to tailor standards, implement encryption...Senior
$60 per hour
...Regulatory Affairs Specialist Our client, a leading organization in the medical device and diagnostics industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs department...Hourly payTemporary workMonday to FridayShift work$183.85k - $242.1k
Understand end to end echo system of data flow process. Telecommuting permitted 100% of the time from anywhere w/in the US. $183,851 - $242,100/yr. Actual compensation packages take into acct a wide range of factors that are unique to each candidate. recblid qkn4rbhg...SeniorRemote workConfidential
Irvine, CA1 day ago- ...supporting the Consumer Markets Division (CMD) business unit in reviewing and approving marketing and sales material, providing regulatory consultation, and providing solutions to help meet the business needs and regulatory requirements. You will fill an existing role...SeniorWork at office
Pacific Life
Newport Coast, CA5 days ago $70k - $85k
...individual to join our team as a Senior Marketing Compliance Specialist. The successful candidate will be responsible for ensuring that... ...materials and communications related to mortgage loans adhere to regulatory requirements and internal policies. This role requires a deep...SeniorWork experience placementLive outWork at officeRemote workVisa sponsorship2 days per week3 days per weekKIND LENDING LLC
Santa Ana, CA4 days ago- ...Sr. Business Systems AnalystIrvine, CAExperience Sr. BSA with very good understanding on Asset Management products from Seismic. Good understanding of Quarter Book publishing by Asset Management Firms. Should have strong thinking/analytical skills on complex business...Senior
ClifyX
Irvine, CA1 day ago - An architecture firm that specializes in designing innovative and functional healthcare facilities is seeking a Senior Project Architect to help them design and review architectural and engineering plans while ensuring compliance with health and safety regulations at their...SeniorFor subcontractor
Blueprint Hires
Irvine, CA2 days ago - ...Sr. Project Manager needed for contract-to-Hire opportunity with Healthcare client to consult within ePMO and eventually move into leadership role upon conversion. Must Haves: * 4-yr Degree (Preferably in CS or related) AND PMP/Scrum/Agile Certification...SeniorContract workLocal area
3B Staffing LLC
Irvine, CA4 days ago - ...Job Description Job Description Regional CPA firm seeking to add a Tax Manager, Sr. Tax Manager to its staff. The Tax Manager, Sr. Tax Manager will be responsible for the efficient, accurate, complete and timely preparation and review of tax returns for our diverse...Senior
CPA firm
Irvine, CA4 days ago - Senior ServiceNow DeveloperAn employer in the insurance industry is seeking a Senior ServiceNow Developer to join a fully remote team. On a daily basis, this person will partner with stakeholders across IT and business teams to gather requirements, design solutions, and...SeniorRemote work
Insight Global
Irvine, CA1 day ago - ...Sr. Electrical EngineerLocation: Irvine, CA - OnsiteSkill Matrix:Must have skills:Embedded systemsFirmware integrationPower ElectronicsMotor... ...with defense industry standards, customer specifications, and regulatory requirementsCollaborate with cross-functional teams including...Senior
Saxon Global
Irvine, CA19 hours ago - The ideal candidate will be responsible for creating and implementing project and bid strategies. You will do so by analyzing project proposals and historical cost data. Ultimately, your work will help us develop new business opportunities. Apply fast, check the full...SeniorWork at office
Saarman Construction, Ltd.
Irvine, CA3 days ago - ...Job Description Job Description We're Hiring: Sr. Manufacturing Associate – Downstream Are you an experienced biologics manufacturing professional looking to contribute to the development of life-saving therapies? looking for a Sr. Manufacturing Associate – Downstream...Senior
BioTalent
Tustin, CA3 days ago - Irvine, United States o be successful as a senior accountant, you should have a solid working knowledge of Generally Accepted Accounting Principles (GAAP) and strong financial analysis skills. An outstanding senior accountant should also possess strong Excel skills, be...SeniorWork at officeLocal area
Talent Elite Group
Irvine, CA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Regulatory Affairs Specialist. Be the first to apply!
Related searches
- compliance analyst Irvine, CA
- regulatory compliance specialist Irvine, CA
- regulatory affairs specialist Irvine, CA
- legal compliance analyst Irvine, CA
- regulatory compliance associate Irvine, CA
- cybersecurity policy and compliance analyst Irvine, CA
- compliance specialist Irvine, CA
- coding compliance specialist Irvine, CA
- compliance consultant Irvine, CA
- compliance associate Irvine, CA