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.
- ...biotechnology company in New York seeks a Senior Regulatory Affairs Manager. This role involves... ...for a portfolio of cosmetics and medical devices. Responsibilities include defining regulatory... ...and a proven ability to manage submissions efficiently. The position offers...SeniorRegulatoryMedical device
- A leading biotech firm in New York is looking for a Senior Regulatory Affairs Manager to shape its regulatory strategy across... ...treatments. This high-impact role involves managing submissions for cosmetics, medical devices, and therapeutics, while ensuring alignment between...SeniorRegulatoryMedical device
- 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
$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 job- ...support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint... .... Visit or follow MMS on LinkedIn. Senior Biostatistician: Responsibilities:...SeniorRegulatoryMedical deviceRemote job
- 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
$120k - $135k
...We're looking for a hands-on Senior Manager of Media Relations Strategist who can bring an established communications... ...conference opportunities, award submissions, and executive platform... ...activity, and relevant policy or regulatory developments to inform communications...SeniorRegulatoryWork at officeLocal area- 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- ...imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) by determining safety, effectiveness, and clinical... ...product success, including (but not limited to): SaMD regulatory submissions (e.g., 510(k)) Sponsored research agreements Product...SeniorRegulatoryMedical deviceVisa sponsorshipWork visa
$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$94.3k - $129.95k
...highly skilled and motivated Senior Process Engineer II with a... ...endotoxin testing programs in the medical device industry. The successful... ...compliance with relevant regulatory requirements such as ANSI/AAMI... ...integralife.com. UNSOLICITED AGENCY SUBMISSION Integra LifeSciences does...SeniorRegulatoryMedical deviceTemporary work$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$152.62k - $209.85k
Senior Manager, Regulatory Affairs - OTC You will oversee end‑to‑end regulatory activities for the... ..., including monograph/NDA drugs and medical devices. The role involves prioritising projects... ...contributors to ensure timely submission and approvals. Conduct portfolio‑level...SeniorRegulatoryMedical deviceWork at office3 days per week$168.68k - $189.5k
Otsuka Pharmaceutical Co., Ltd is seeking a Senior Field Reimbursement Manager to work with hospitals and physicians in the West region... ...will possess extensive experience in reimbursement within the medical device industry, along with superior communication skills to convey...SeniorMedical device$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$110k - $115k
...Description Job Description Senior International Regulatory Affairs Specialist... ...-body portable ultrasound device, which is now on its best-... ...initiative. In addition to its medical imaging products,... ...strategies and drive high-quality submissions across complex...SeniorRegulatoryMedical deviceWork at officeImmediate startWork visaFlexible hours2 days per week$53.96k - $79.79k
...be. And to make it matter. Job Description The Senior Associate, Regulatory Operations is responsible for ensuring regulatory submissions follow the protocols established by our pharmaceutical and medical/surgical device clients for promotional materials. This includes...SeniorRegulatoryMedical deviceTemporary workFreelanceWork at officeFlexible hours- ...US031 Marsh & McLennan Shared Services LLC in New York seeks a Senior Executive Compensation Manager to advance its compensation strategy and regulatory compliance. This hybrid role involves collaboration across various departments and entails developing executive compensation...SeniorRegulatory
$133k - $212k
Senior Systems V&V Engineer The Senior Systems V&V Engineer is... ...integration verification, and regulatory compliance. Your role... ...a key partner in regulatory submissions, audits, and inspections by... ...the system or product level, medical device industry strongly preferred....SeniorRegulatoryMedical deviceFull timeWork at officeWork visaRelocation package3 days per week- Syneos Health is seeking a Principal Statistician Oncology with Submission Experience to lead and mentor biostatistics personnel. You'll... ...trials, and strong proficiency in statistical programming and regulatory submissions. This role includes project leadership and...SeniorRegulatory
$119.3k - $159.3k
BeiGene, Ltd. is seeking a Regulatory Writer to join its dynamic team in the United States. This role involves developing high-quality clinical and regulatory documents to ensure timely submissions of products. You will also mentor junior writers, ensuring compliance with...SeniorRegulatory$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- ...Senior Managing Counsel, Privacy & Cybersecurity About the Company Multinational... ...health data compliance. Industry Medical Devices Type Privately Held About the... ...ensuring compliance with contractual and regulatory obligations, and managing legal risks...SeniorRegulatoryMedical device
- MSD Malaysia is looking for a Senior Statistical Programmer to oversee and manage submission data standards for regulatory applications. This hybrid role requires expertise in SAS... ...to the development of life-saving medical products. #J-18808-Ljbffr MSD MalaysiaSeniorRegulatory
$130k - $133k
A healthcare company is seeking experienced Medical Device Sr. CRAs to join their team. This role requires 3+ years of monitoring experience... ...monitoring, project management, and ensuring compliance with regulatory guidelines. Candidates must have a life science degree or...SeniorRegulatoryMedical device- Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...communication with teams. Benefits include comprehensive medical coverage, 401(k) match, stock incentives, and generous PTO...SeniorRegulatoryRemote job
- ...optimize consumer finance products. Responsibilities include developing financial models, overseeing program launch, and ensuring regulatory compliance. The ideal candidate will have at least 10 years of experience in Consumer Retail finance, strong analytical skills,...SeniorRegulatoryRemote job
- ...of labeling components for submission to regulatory agencies, participation in... ...generics, private labels, device/combination products Ability... ...Pharmacovigilance, Global Medical Affairs, Legal,... ...Proficient in presenting to senior management when required....SeniorRegulatoryLocal area
- JPMorgan Chase & Co. is seeking an experienced Senior Business Relationship Manager to focus on Government Not-for-Profit clients. The... ..., delivering customized banking solutions, and adhering to regulatory requirements. Candidates should have a minimum of 8 years of experience...SeniorRegulatory
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