Senior Regulatory Strategist, Medical Devices Submissions
Merit-Medical-Systems-Inc.
Merit Medical Systems Inc. is looking for a Regulatory Affairs Specialist to contribute to medical device regulatory submissions and compliance. Candidates must have at least 8 years of experience in regulatory submissions within the medical device industry. The role also involves developing regulatory strategies and maintaining communication with key stakeholders while ensuring compliance with Health Canada requirements. Strong project management and communication skills are essential. Join us in improving lives with innovative medical devices. #J-18808-Ljbffr Merit-Medical-Systems-Inc.
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...SeniorRegulatoryMedical deviceRemote work- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist... ...involves supporting US and EU regulatory submissions while ensuring adherence to regulations concerning medical devices. The ideal candidate should have over 7 years...SeniorRegulatoryMedical deviceWork at office
- Meridian Bioscience International Limited is seeking a Regulatory Affairs professional responsible for supporting quality processes and regulatory compliance for medical devices. This role includes drafting submissions and ensuring adherence to regulations throughout the...SeniorRegulatoryMedical device
- Director, Regulatory Affairs - Permanent - Remote Proclinical is seeking a (Senior) Director, Regulatory Affairs for an exciting... ...while overseeing regulatory submission mechanics executed by external... ..., biotechnology and medical device companies. #J-18808-Ljbffr...SeniorRegulatoryMedical devicePermanent employmentRemote work
$92k - $138k
...Under limited supervision, the Senior Regulatory Specialist is responsible... ...regulatory strategies for new devices, new launch markets, and... ...completing and maintaining product submissions and regulatory filings for... ..., etc.), engineering, medical technology, regulatory science...SeniorRegulatoryMedical deviceMinimum wageLocal areaWorldwide$55.03 per hour
...poster from Infosoft, Inc. Job Title: Senior Regulatory Affairs Specialist Pay Rate: $50 to $... ...regions ) Our Client is a Global medical device Manufacturer. We are looking for a Senior... ...assigned products. Create regulatory submissions (exercising judgment to protect...SeniorRegulatoryMedical deviceFull timeWork at officeRemote work- Overview Senior Medical Writer (Remote) at MMS. Join to apply for the Senior Medical Writer... ...pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across...SeniorRegulatoryMedical deviceRemote jobFull time
$115k - $185k
Senior Regulatory Affairs Specialist (Senior IC or Manager) Lexington Medical, Inc. is hiring a Senior Regulatory Affairs professional to lead global medical device submissions and regulatory strategy. For candidates who are not local to the Boston area, this role can...SeniorRegulatoryMedical deviceFull timeLocal areaRemote workFlexible hours- BeiGene, Ltd. is looking for a Senior Associate to manage U.S. regulatory submissions including INDs, NDAs, and BLAs. The role requires excellent communication, organizational skills, and a proactive approach. Experienced professionals with a scientific background and...SeniorRegulatory
- EY is seeking a Senior Manager for its Life Sciences Regulatory Submissions practice in Hoboken, NJ. This pivotal role involves leading the team and driving growth while establishing EY as a leader in regulatory compliance. The ideal candidate will have extensive knowledge...SeniorRegulatory
- Amgen SA is looking for a Regulatory Affairs Senior Associate to assist in creating and submitting regulatory documents essential for FDA compliance and submissions. The ideal candidate will support various regulatory activities, ensuring all documentation is accurately...SeniorRegulatory
$73.35k - $105k
...Senior Statistical Programmer (Remote) General Information Location: Cary, NC, Remote... ...clinical trial data analysis and regulatory submissions. This role leads programming activities... ..., vaccines, biotech, or medical device industry required. Phase 1-4 clinical...SeniorRegulatoryMedical deviceFull timeLocal areaRemote workFlexible hours- ...DAYWork Schedule:Why Merit?At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is... ...Manifesto.2. Align with agreed regulatory strategies and timeframes,... ...regional requirements for product submissions are clearly understood and...SeniorRegulatoryMedical deviceLocal areaShift work
$183k - $228.8k
...Industrial Quality & Research, Medical Technology, Consumer... ...Role What\'s the role? The Senior Advisor, Regulatory and Clinical Affairs, US is... ...support of a variety of FDA submissions including pre-submissions (... ...(PMAs) and investigational device exemptions (IDEs). In addition...SeniorRegulatoryMedical deviceLocal areaRemote work- argenx SE is seeking a Senior Medical Writer to author and manage contributions for regulatory submissions, ensuring compliance with medical writing standards. The successful candidate will have a strong background in pharma or biotech, with at least 3 years of clinical...SeniorRegulatory
$115k - $165k
...and manufacturing process validation for electromechanical medical devices. This role requires a minimum of 10 years of experience in manufacturing... ...in electromechanical processes, and expert knowledge in regulatory requirements. The position offers a competitive salary...SeniorRegulatoryMedical device$103k - $130k
...initiation, execution, monitoring and close-out of IVD and medical device clinical trials at external clinical research sites... ...entry and/or outstanding queries Manage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to...SeniorRegulatoryMedical deviceHourly payContract workRemote workWork from homeWorldwideFlexible hoursNight shift- ...A global professional services firm is seeking a Senior in Indirect Tax for their office in New York City. The role involves advising on indirect tax regulatory changes, managing compliance processes, and identifying optimization opportunities. Suitable candidates must...SeniorRegulatoryWork at office
- ...firm that works with pharmaceutical, biotech, and medical device organizations to address complex regulatory and operational challenges. The firm has deep expertise... ...Our client is seeking an experienced Consultant or Senior Consultant with a strong background in either...SeniorRegulatoryMedical deviceFull timeRemote work
- Vir Biotechnology is seeking a Senior Regulatory Writer to support regulatory submission writing. This role requires collaboration with senior management and other leads to ensure consistent messaging and compliance. The successful candidate will have extensive experience...SeniorRegulatory
$100k - $160k
...manufactures, and markets hemostatic medical devices utilizing the company’s... ...at Description: The Senior Medical Device R&D Engineer... ...with all quality and regulatory requirements. They will be responsible... ...FDA/regulated authority submissions, Provide support to...SeniorRegulatoryMedical deviceFull timeTemporary workPart timeApprenticeshipWork experience placementLocal area$100k - $150k
Tempus, Inc. is seeking a Senior Quality Engineer to lead verification and validation of systems supporting Tempus Medical Devices. This role involves ensuring regulatory compliance, developing CSV policies, and collaborating with cross-functional teams. Candidates should...SeniorRegulatoryMedical device- Cresilon, Inc. is seeking a Senior Medical Device R&D Engineer based in Brooklyn, New York. This role involves leading the design and development... ...new medical devices, ensuring compliance with quality and regulatory requirements. Candidates should have at least 5 years of...SeniorRegulatoryMedical device
$95k - $130k
Integra LifeSciences is looking for a Medical Writing Manager to prepare complex clinical... ...cross-functional stakeholders to meet regulatory objectives. With a strong background in... ...writing and at least 10 years in the medical device industry, you will ensure high-quality...SeniorRegulatoryMedical device- ...infrastructure projects. This role involves environmental compliance, permitting strategies, and collaboration with various teams to ensure regulatory requirements are met. Ideal candidates will have a relevant degree, experience in environmental projects, and strong analytical...SeniorRegulatory
- Meridian Bioscience International Limited is seeking a Regulatory Affairs Specialist to support quality and regulatory processes for medical devices. The role involves ensuring compliance throughout the product lifecycle and providing regulatory guidance. Ideal candidates...SeniorRegulatoryMedical device
$103k - $130k
...seeking a Sr. Clinical Research Associate to manage IVD and medical device clinical trials from start to finish. This fully remote role... ...significant clinical research experience, with the ability to navigate regulatory requirements. Competitive salary range of $103,000 to $130,00...SeniorRegulatoryMedical deviceRemote job- ...finance and compliance regulations. The successful candidate will engage clients through personal meetings while ensuring adherence to all compliance mandates. Candidates must possess 5-8 years of experience and relevant regulatory registrations. #J-18808-Ljbffr CitiSeniorRegulatory
- ...implement Global Ethics & Compliance initiatives. The role involves partnering with the Global Compliance Officer to ensure adherence to regulatory obligations while fostering a culture of accountability. Qualified candidates will have a bachelor's degree and 3-5 years of...SeniorRegulatory
- ...global scale. This role We’re looking for a Senior Product Manager to join our growing... ...area, balancing clinical outcomes, regulatory requirements, and commercial priorities... ...Class II regulated product environment (medical device regulation, quality management systems,...SeniorRegulatoryMedical deviceRemote work
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