Regulatory Affairs Specialist
Three Point Solutions
Job Title: Regulatory Affairs Specialist Client: Medical Device Manufacturing Company Duration: 12 Months with possible extension Location: Remote Shift: 1st Shift Description
#ZR
- Direct or performs coordination and preparation of document packages for regulatory submissions related to the MiniMed separation from all areas of company, internal audits and inspections.
- Lead and compile all materials required in submissions related to the MiniMed separation Monitor and improve tracking as well as control systems.
- Update regulatory approval data in various systems to ensure data is kept up to date Keep abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters.
- Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related technical field.
- 2-5 years of regulatory affairs experience within the medical device industry
#ZR
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in United States vacancy
- The Compliance Specialist reports to the Director Legal, Compliance, Privacy & Security (“Director”) and has a key role in supporting the... ...basis.Conduct research and develop written communication on regulatory requirements to ensure ongoing updates upon request. Manage compliance...SuggestedContract work
$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines...SuggestedFor contractorsLocal area- Job Title: Regulatory Affairs SpecialistREMOTEContract: 1 Year and Possibility of ExtensionClient is seeking an experienced Regulatory Affairs contractor to support the preparation and submission of a US FDA 510k and the development of global regulatory documentation,...SuggestedFor contractors
- ...Name: Atrium Medical CorporationJob Location: Merrimack, NH 03054 Employer will allow a hybrid work schedule.Job title: Regulatory Affairs Specialist IIEducation: Bachelor's degree in a scientific or engineering disciplineSOC Code: 13-1041.07SOC Occupation Title: Regulatory...SuggestedWorldwideFlexible hours
- ...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...SuggestedWork at office
$120k - $160k
...members to perform at a higher level through a deep understanding of their bodies and daily lives.WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health team.As the Regulatory Affairs Specialist II, Expansion, you...Full timeWork at officeRelocation$107.2k - $160.8k
...font-size: 30px; font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and...Work at officeLocal areaImmediate startFlexible hours- Brecksville, OHDescriptionJob Title: Regulatory Affairs SpecialistDepartment: RegulatoryReports To: Director of Regulatory AffairsFLSA Status: ExemptSupervise the work of others: NoPosition Summary:This position is responsible for preparing submissions to various regulatory...Work experience placementWork at office
- The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and...
- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with...
- ...financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual...Work at officeImmediate start
- ...approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.A Regulatory Affairs Specialist II position is available in the Diamond Research Laboratory. You will assist and support internal and external PIs, for...Work experience placement
- ...both internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical... ...Master s Degree a plus• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or...Work at officeLocal areaImmediate start
- ...is working in the CMC area. Relevant experience is requiredExperience: 3 to 6 yearsExperience with drug/biologics licensurePrior regulatory experienceTechnical writing experience (CMC experience )Scientific background,Required Skills:CMC/ Regulatory writing experienceScientific...Work at officeImmediate start
- Overview This is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to...H1bWork at officeLocal areaRemote workAfternoon shiftEarly shift
- The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. Relies on extensive experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance...
- Job-ID31525652Reference25-04486 Responsibilities: The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality...
- ...439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic... ...equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation...Work at office
- ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the... ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
- ...execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the...Immediate start
- ...education. Responsibilities may include the following and other duties may be assigned: Prepare, coordinate, and compile regulatory submission packages (e.g., registrations, renewals, design change submissions) to ensure timely approvals in Israel and potential...Remote workFlexible hours
- ...Regulatory Affairs Specialist Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure TM. Everything we do is aligned with this singular purpose. We work...Contract workInterim roleRemote workFlexible hours
$76k - $121.9k
...Regulatory Affairs Specialist II, MedTech Neurovascular At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and...Temporary workLocal areaRemote work- ...Associate Regulatory Affairs Specialist Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients...Temporary workWork at officeImmediate startRemote workFlexible hours
- ...Seeking a remote, 12-month contract Global Regulatory Affairs Specialist, the candidate will coordinate and support the maintenance of labeling intelligence, ensuring compliance and alignment with business needs while managing label tracking strategies throughout the product...Contract workLocal areaRemote work
$71.6k - $119.3k
...our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from...Work at officeRemote workWorldwideHome officeFlexible hours- ...To support regulatory compliance efforts, the contract Regulatory Affairs Specialist will manage regulatory submissions, provide guidance on global regulatory strategies, and represent the regulatory function within product development teams. Key Responsibilities Create...Contract workWork at officeRemote work
$120k - $150k
...Certificates, Waivers & COAs Partner closely with engineering and flight test teams to ensure compliance alignment early in design Regulatory Engagement Serve as primary Pivotal representative to: Aeronautical Authorities including FAA (and offices including AIR, AFS,...Work at officeLocal areaRemote work$80k - $96k
...simple-do what's right for patients, surgeons, tissue donors, and their families through our guiding principles. The Regulatory Affairs Specialist is responsible for working with product development and manufacturing management to ensure that the product development...Temporary workWork at officeLocal areaRemote workMonday to FridayFlexible hoursShift work- ...Job Responsibilities Determine international regulatory submission and approval requirements Compile, prepare, review regulatory submission with in-country representatives and ensure on-time submission to relevant authorities Anticipate regulatory obstacles and...Work experience placement
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
Related searches
- quality compliance specialist United States
- junior regulatory affairs specialist United States
- regulatory compliance analyst United States
- junior compliance analyst United States
- compliance support specialist United States
- medicare compliance specialist United States
- regulatory analyst United States
- entry level compliance analyst United States
- pharmaceutical compliance officer United States
- senior compliance officer United States

