Strategic Regulatory Lead — Medical Devices
DEKA Research and Development
A leading medical device company in Manchester, NH is seeking a Regulatory Affairs Project Manager. The role involves defining and executing regulatory strategies for FDA approval of innovative life science devices, mentoring staff, and leading FDA interactions. Candidates should have a BS in a related field and a minimum of 5 years' experience in medical device regulations. The position offers the opportunity to contribute to meaningful projects in an innovative and fast-paced environment. #J-18808-Ljbffr DEKA Research & Development
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Strategic Regulatory Lead — Medical Devices in Manchester, NH vacancy
- Travere Therapeutics is seeking an Associate Director, Strategic Procurement to lead strategic sourcing, outsourcing, and financial oversight... ...role partners with Clinical Operations, Development, Regulatory, Medical Affairs, and Finance to optimize external spending and...Regulatory
- ...assigned tasks and meet deadlines.Ability to think strategically and tactically.Frequent reading, writing, and... ...quality systems in a pharmaceutical/biotech/medical device environment is preferred.Familiarity with regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820;...RegulatoryMedical deviceFull timeContract work
- ...Provide technical leadership and strategic oversight for the Operations... ...Bedford campus.Build and lead a team of process... ...Expert (SME) during customer and regulatory audits.Interface directly with... ...Biopharmaceutical / Biotechnology) and/or Medical Device with GMP industry experience...RegulatoryMedical deviceFull timeWork experience placement
- ...new business opportunities across the medical device, diagnostics, and digital health sectors... ...Qualify opportunities based on client needs, strategic fit, timing, and funding. Secure... ...development, FDA design controls, and related regulatory requirements. Demonstrated ability to...RegulatoryMedical device
Suntra MedTech
Bedford, NH1 day ago - ...organization, the Validation Director will lead pharmaceutical and medical device validation operations and staff... ...duties may be assigned.Provide strategic and operational leadership to the Validation... ...to support corporate and regulatory goals.Guide the strategy for development...RegulatoryMedical deviceFull timeContract workTemporary workLocal areaRemote work
- ...seeks a qualified individual to assess complaints regarding medical devices. The role requires strong knowledge of FDA regulations and experience... ...opportunities to work in a fast-paced environment alongside regulatory agencies and healthcare professionals, ensuring high...RegulatoryMedical device
- Travere Therapeutics is seeking an Associate Director of Medical Writing to lead regulatory submission efforts, ensuring adherence to quality and strategic oversight. The role requires collaboration with cross-functional teams and involves authoring a range of regulatory...Regulatory
- ...Verification & Validation Test Engineer to work in a dynamic medical device R&D environment. This is a high visibility role with a direct... ...Hazard Analysis, and FTAsParticipating and contributing toward regulatory and agency submissionsAuthoring Quality Plans, Test Summaries...RegulatoryMedical device
DEKA Research & Development
Manchester, NH4 days ago $110k - $135k
...Lead Analyst, Corporate FPA At Liberty Utilities in Litchfield Park, Arizona, United... ...Align planning assumptions across FP&A, Regulatory, Treasury, and Tax. Translate diverse... ...results in a way that supports strategic decision-making. Anticipate executive...RegulatoryWork experience placementFlexible hoursArizona Staffing
Manchester, NH2 days ago- DEKA Research and Development is seeking a Regulatory Affairs Project Manager to lead regulatory strategy for medical device programs. You will define requirements, prepare submissions, and guide cross‑functional teams to approvals and clearances. You will interact with...RegulatoryMedical device
- ...Regulatory Affairs Project Manager DEKA Research & Development has an immediate opening... ...Manager to contribute to a dynamic, medical device research and development environment. The... ...establishing regulatory requirements and leading the preparation and submission of 510(k...RegulatoryMedical deviceWork experience placementImmediate start
DEKA Research & Development
Manchester, NH4 days ago $115k - $155k
...Controller, North America / Global SOX Lead Hybrid / Full Time / Portsmouth, NH At... ...Big Four public accounting experience. Medical device, biotechnology or pharmaceutical industry... ...Participate in month-end close, audit cycles and strategic accounting initiatives. Opportunity to...Medical deviceFull timeWork at officeLocal area3 days per week- ...Description Ready to build devices that matter? If you thrive on... ...of assembling and verifying medical devices. Impact you’ll make... ...requirements aligned with customer and Regulatory Affairs expectations; follow... ...with Engineers and line leads to troubleshoot and update...RegulatoryMedical deviceImmediate start
Connexion
Manchester, NH9 days ago $425k
...vision of becoming a leading biopharmaceutical company... ...Development and Chief Medical Officer and serves as... ..., the CSO provides strategic scientific leadership... ...combination products, medical devices, and emerging... ...technical, clinical, regulatory, and commercial strategies...RegulatoryMedical deviceTemporary workRemote work- ...evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of... ...with GMP quality systems in a pharmaceutical/biotech/medical device environment is a mustThorough knowledge of FDA regulations (i...RegulatoryMedical deviceFull timeContract work
- ...COMPANY OVERVIEW: Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing... ...products meet established quality requirements, regulatory standards, and internal procedures prior to release for distribution...RegulatoryMedical deviceWork at office
Merrimack Manufacturing
Manchester, NH4 days ago $19 per hour
...Job Title Quality Inspector – Medical Device Manufacturing Overview The Quality Inspector ensures that all manufactured plastic sheet and... ...inspections, ensuring that product quality is consistent with regulatory and customer requirements. Responsibilities Perform basic...RegulatoryMedical deviceHourly payTecomet
Manchester, NH5 days ago- ...updates, as directed.Participate in or lead audit preparation and reconciliation. Support... ...in the Biotech, Pharmaceutical or Medical Device industries is required. Previous... ...required.Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,...RegulatoryMedical deviceFull time
- ...equipment and lyophilization. Independently lead Critical and Plant Utility projects... ..., preferably in the biotechnology, medical device or pharmaceutical industry.Strong understanding... ...non-GMP change control, maintaining regulatory complianceExperience with aseptic...RegulatoryMedical deviceFull timeFor contractors
- ...R&D, on behalf of Millyard Advanced Medical Products, is looking for a Product Complaints Engineer - Team Lead to work in a dynamic Medical Device environment. The position reports to... ...Administration (FDA) regulations / other regulatory requirements. Identify and make...RegulatoryMedical deviceFull timeContract workFor contractors
DEKA Research & Development
Manchester, NH22 days ago - ...COMPANY OVERVIEW: Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing... ...Merrimack Manufacturing is looking for a Manufacturing Team Lead to perform various functions in ensuring production processes...Medical deviceFull timeWork at officeDay shift
Merrimack Manufacturing
Manchester, NHmore than 2 months ago - ...support the development of life-changing medical devices. How you will make an impact as a... ...implementation of critical software tools. Lead requirement capture discussions to... ...definition and management for regulatory compliance a plus About DEKA: One...RegulatoryMedical deviceFull timeWork at office
DEKA Research & Development
Manchester, NHmore than 2 months ago - ...and Development, on behalf of Millyard Advanced Medical Products, a Manufacturer of Record for innovative medical devices, has an immediate opening for an Experienced... ...Conformance, sterilization records, and other regulatory paperwork) for completeness and accuracy.Prepares...RegulatoryMedical deviceWork at officeImmediate start
DEKA Research & Development
Manchester, NH4 days ago - ...excellent attention to detail to assemble medical devices. Applicants must be self-sufficient in... ...practices to satisfy customer and Regulatory Affairs requirements. Read and/or understand... ...sheets.Work with Engineers and line leads to resolve issues and correct procedures...RegulatoryMedical deviceImmediate startShift workNight shift
Merrimack Manufacturing
Manchester, NH2 days ago - ...impact Responsible for reviewing complaints related to potential medical device issues. Perform product complaint evaluations with minimal... ...U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements. Identify and make sound decisions regarding medical...RegulatoryMedical deviceFor contractorsInternship
DEKA Research & Development
Manchester, NH1 day ago - ...Quality EngineerMerrimack Manufacturing is a medical device manufacturer located in the Manchester... ...Engineer (Sr. SQE) is responsible for leading supplier quality activities across both... ...of consistently meeting quality, regulatory, and performance expectations. This role...RegulatoryMedical deviceContract workRemote work
Merrimack Manufacturing
Manchester, NH5 days ago $100k
...in Manchester, NH is seeking a seasoned financial professional to lead budgeting and forecasting efforts. This role involves analyzing financial performance and developing reports that support strategic initiatives. You will collaborate with various teams to ensure data...- ...packaging processes, supporting quality, regulatory compliance, continuity of supply, and... ...manufacturing processes.Roles & Responsibilities:Lead and execute packaging engineering... ...presentation skills.Experience in the medical device, pharmaceutical, or healthcare industry...RegulatoryMedical deviceFlexible hoursNight shift
Katalyst HealthCares & Life Sciences
Manchester, NH2 days ago $28 - $35 per hour
...Services may serve as technical advisor to the medical and clinical staff in the safe operation... ...Special Projects as assigned Regulatory Compliance -Ensure the accuracy and integrity... ...and accurate inventory of medical devices, including trial and evaluation, rental,...RegulatoryMedical deviceHourly payFor subcontractorRemote workWork from home- Armiusa seeks a Senior Regulatory Affairs Consultant to develop regulatory strategies and ensure compliance for complex biologics and devices. Candidates should have extensive experience in regulatory affairs and a strong educational background in life sciences or engineering...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Strategic Regulatory Lead — Medical Devices. Be the first to apply!
Related searches
- food regulatory Manchester, NH
- regulatory contract Manchester, NH
- regulatory Manchester, NH
- regulatory law Manchester, NH
- regulatory technician Manchester, NH
- regulatory engineer Manchester, NH
- entry level medical device sales Manchester, NH
- medical device sales internship Manchester, NH
- medical device sales Manchester, NH
- medical device sales no experience Manchester, NH