- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Battelle Memorial Institute (MA)
- …Healthcare innovation is at the core of what we do. Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization's ... regulatory affairs strategy for our Health Business...operations in **_Columbus, OH; Boston, MA_** but may be remote . **Major Responsibilities** + Direct all regulatory … more
- J&J Family of Companies (Boston, MA)
- Senior Regulatory Affairs Specialist - 2406173183W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory ... has a proven track record for growth, integrity and innovation. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to… more
- Philips (Cambridge, MA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... strategy in the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips… more
- Medtronic (Boston, MA)
- …guidance you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory ...Center (BIDMC). The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners with the ... of the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription drug distribution… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... values by staying **True to Life.** **Job Description** The Sr . L&D Specialist, Global QMS Training will serve as...L&D Specialist, Global QMS Training will serve as a senior individual contributor within Quality. This individual will support… more
- Merck (Boston, MA)
- **Job Description** The Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... with key opinion leaders of diverse expertise and backgrounds, and assist medical affairs in developing and guiding advisory boards + Represent our company's Animal… more
- Merck (Boston, MA)
- …+ Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... Participates & provides inputs on site selection and validation activities. **Performs remote and on-site monitoring & oversight activities using various tools to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... by staying **True to Life.** **Job Description** The Manager, Senior Global MDR Submission is responsible for managing Market...for managing Market Quality- COE MDR team for the regulatory assessment and submission of Medical Device Reports to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Sanofi Group (Cambridge, MA)
- We are currently seeking a Global Regulatory Affairs Lead (GRL) who will be the fully accountable decision maker for the development & execution of creative, ... relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global), in early and… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... talented and dedicated colleagues while developing and expanding your career. The Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... staying **True to Life.** **Job Description** Leads and directs regulatory compliance communications to ensure compliance of the Global...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... our core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer, Software is responsible for the product-related supplier… more