Senior Regulatory Affairs Lead, Class III Medical Devices
BioTalent
BioTalent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment. The role centers on leading FDA submissions (including PMAs), global registrations, and guiding design controls, risk management, and product commercialization throughout development. #J-18808-Ljbffr BioTalent
Vacancy posted 5 hours ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead, Class III Medical Devices in Oklahoma City, OK vacancy
- Our client, an innovative medical device company, is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy and submissions for complex Class III products. This is a hands-on role... ...regulatory professional who can both lead and execute. The successful...SeniorMedical deviceShift work
- ...and execute global regulatory strategies for... ...conformity assessments). Lead regulatory risk... ...the Regulatory Affairs function on... ...new and existing devices. Lead and influence... ...experience within the medical device industry... ...experience with Class I/II/III/IV software...SeniorMedical deviceWork at office
- ...Life Sciences is seeking an experienced QC Analyst III to join our GMP-regulated Quality Control team. The role leads analytical testing across early development to... ...manufacturing, ensuring data integrity and regulatory compliance. You will work with HPLC/UPLC, GC, UV...Senior
- Philips is seeking a Senior Quality Operations Manager-Advanced Imaging in Bedford, MA to lead quality operations for medical devices. The role drives CAPA/NC/QN processes, process... ...coordinating across R&D, manufacturing, and regulatory affairs to uphold regulatory standards and...SeniorMedical device
- Mass Digital Health is looking for a Senior Regulatory Affairs Specialist to support Ultrasound... ...guiding cross-functional teams, and leading regulatory intelligence initiatives.... ...have over 5 years of experience in medical device regulatory affairs, with expertise in...Medical deviceWork at office
- ...What You’ll Do Leading PMA supplements, IDEs, and/or 510(k) submissions Owning regulatory strategy for product changes and lifecycle... ...: 5+ years of Regulatory Affairs experience in medical devices Direct hands-on... ...currently operating at a Senior level and ready for greater...SeniorMedical deviceRemote work
- Avalyn Pharma is seeking a Senior Manager, Regulatory Affairs to shape global regulatory strategy for inhaled drug-device products. You will lead regulatory submissions, health authority interactions, and cross‑functional planning from early development through late-stage...SeniorRemote job
- Philips in Bedford, MA is seeking a Senior Quality Manager-Advanced Imaging to lead the QMS and design assurance... ...product lifecycle. You will guide regulatory readiness, oversee audits, and... ...continuous improvement in a regulated medical device environment. The role requires 8...SeniorMedical deviceWork at office
$94k - $150k
Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist, Ultrasound... ..., Declarations of Conformity, and Medical Device Licenses—for various global markets.... ...major changes to existing products. Lead global regulatory intelligence initiatives...SeniorMedical deviceFull timeWork at officeWork visaRelocation package3 days per week$120k - $140k
...seeking a Program Manager for their Beverly, MA location in the medical device sector. The Program Manager will oversee product development... ...budgets, and mentor teams while ensuring compliance with regulatory standards. This role requires over 8 years of experience in the...SeniorMedical device- Olympus Corporation in the United States seeks a senior Product Marketing leader for Swan Endosurgical Alliance to drive upstream... ...commercialization. The role requires a strong track record in medical devices marketing, launch planning, and stakeholder communication...SeniorMedical device
$134k - $213k
Senior Quality Operations Manager-Advanced Imaging... ...ensuring compliance with regulatory standards and... ...manufacturing, and regulatory affairs to address process... ...products/services, often leads a cooperative effort among... ...regulated (ISO 13485) medical device quality operations/...SeniorMedical deviceFull timeWork at officeLocal areaImmediate startWork visaRelocation package3 days per week- ...: Why Merit? At Merit Medical, our mission is to create... ...innovative medical devices that improve lives. Our... ...developing best in class quality systems. Coordinates... ..., international regulatory affairs/quality assurance, and... ...their jobs. Risk category III states employment and...SeniorMedical deviceLocal areaShift workNight shift
- Jobtailor is seeking an experienced Regulatory Affairs professional to develop and execute global regulatory strategies for medical devices, including software-based solutions. You will lead submissions and agency interactions across FDA, EU MDR, NMPA, PMDA, and TGA. Collaborate...Medical device
- ...compliance matters, and counseling business leads across the globe on a wide‑range of... ...clients is a must. Job Details Seniority level: Associate Employment type: Full... ...firm and in‑house experience preferred. Medical device or other regulated industry experience....SeniorMedical deviceFull time
- ...Senior Director of Strategic Alliances About the Company A contract development and manufacturing company serving medical device OEMs. Industry Medical Devices Type Privately Held About the Role The Company is seeking a Senior Director of Strategic...SeniorMedical deviceContract work
$151k - $215k
...do. As part of our Medical Affairs team, you'll... ...inspiring journey. The Senior Principal... ...trial designs to regulatory submissions while... ...make an impact: Lead end-to-end evidence... ...Preferred): Medical device industry experience... ...technologies, world-class evidence and...SeniorMedical deviceFull timeRemote work- Devon is seeking a Lead Financial Reporting Accountant in Oklahoma City to independently manage the preparation, analysis, and distribution of monthly, quarterly, and annual financial statements for internal and external use. You will ensure GAAP and SEC compliance while...Senior
$220k - $260k
...annually Job Title: Senior Medical Director -... ...Medical Director to lead the clinical development... ...for a first-in-class therapeutic candidate... ...medical and regulatory oversight. You will... ...Disease, US Medical Affairs Vice President International... ...and Medical Devices Vice President,...SeniorMedical deviceFull timeRemote work- ...Affordable in MA is seeking an Affordable Housing Compliance Specialist to ensure adherence to HUD, LIHTC, PBS8, PBV, RAD, and related regulatory agreements. Located in Massachusetts, reporting to the Director of Regulatory Compliance, the role requires attention to detail...Senior
- Prism Bank is seeking a senior BSA/AML Compliance Officer to lead the Bank's anti-money laundering program and regulatory risk management. The role emphasizes expertise in Verafin analytics, SAR/CTR reporting, and enterprise-wide risk assessments across departments. You...Senior
- • Partner with the Device Regulatory Lead on assigned projects • Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross... ...• Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices...SeniorMedical device
- Devon is seeking a Lead Financial Reporting Accountant to independently lead monthly, quarterly, and annual financial reporting with strong GAAP and SEC focus. You will liaise with external auditors, mentor staff, and drive improvements in reporting processes to support...Senior
- Harvard University’s Office of Research and Academic Compliance seeks a Research and Academic Compliance Officer (RACO) to manage cross-school risk and compliance in areas including conflicts of interest, export controls, and international collaborations. The role advises...SeniorWork at office
- Northrop Grumman seeks an FSO/Sr. Principal Industrial Security Analyst 4 for the Oklahoma City, OK site. Lead and execute the facility's industrial security program, ensure NISPOM compliance, and collaborate with program management, contracts, HR, and government customers...Senior
- Lead the end-to-end copy review process for educational and commercial materials... ...Partner with Marketing, Medical Affairs, Legal, and Regulatory stakeholders to align messaging and... ...understanding of healthcare, medical device, or life sciences industry standards...SeniorMedical device
- Prism Bank seeks a seasoned Compliance Officer to lead CRA, HMDA, and Consumer Compliance programs. You will oversee data collection... ...reporting, coordinate examinations, and drive improvements in regulatory readiness across the bank. The role requires extensive experience...SeniorFull time
- United Overseas Bank Limited is seeking an Assistant Vice President for the Specialised Investigations Team to lead complex Anti-Financial Crime investigations and coordinate with compliance, risk and business units. The role emphasizes applying advanced analytics to detect...SeniorOverseas
- Jobtailor in Massachusetts seeks a senior Copy Review Lead to oversee end-to-end review of educational and promotional materials... ..., and consistency. You will partner with Marketing, Medical Affairs, Legal and Regulatory to align messaging and streamline approvals, while mentoring...Senior
- ...role drives growth through strategic planning, leadership, and business development, requiring extensive sales experience in the medical device industry. Your responsibilities include developing business plans and overseeing a sales team while fostering key client...SeniorMedical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead, Class III Medical Devices. Be the first to apply!
Related searches
- srs distribution Oklahoma City, OK
- senior associate architect Oklahoma City, OK
- senior dynamics crm developer Oklahoma City, OK
- senior application security Oklahoma City, OK
- senior account director Oklahoma City, OK
- senior advisor Oklahoma City, OK
- senior cloud data engineer Oklahoma City, OK
- senior customer service manager Oklahoma City, OK
- senior Oklahoma City, OK
- senior customer success engineer Oklahoma City, OK

