- Oracle (Concord, NH)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Cardinal Health (Concord, NH)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- GRAIL (Concord, NH)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Dentsply Sirona (Waltham, MA)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...13485, EU MDR). + Experience with software as a medical device , AI and/or medical … more
- Otsuka America Pharmaceutical Inc. (Concord, NH)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- ThermoFisher Scientific (Waltham, MA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Fujifilm (Concord, NH)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Takeda Pharmaceuticals (Lexington, MA)
- …councils, inspection support, and industry interactions. + Partner with critical stakeholders in Regulatory Affairs , Device Quality, and PharmSci to ensure ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Massachusetts. This announcement is intended to fill multiple vacancies throughout the Veterans Affairs Medical Center in Bedford, MA. Available shifts could be ... is located in the Nursing Service (Mental Health) at the Bedford VA Healthcare Medical Center, in Bedford, Massachusetts. This is a full time position at 40-hours… more
- Otsuka America Pharmaceutical Inc. (Concord, NH)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- J&J Family of Companies (Danvers, MA)
- … Medical Officer. The MSO will build clear and strong relationships between Medical Affairs , R&D, Quality, Regulatory , Clinical, Epidemiology to allow for ... in Danvers, MA. The MSO role is to provide medical safety stewardship for Medical Device...and safety communications. + Stakeholder Collaboration: Work closely with Medical Affairs , R&D, Quality, Regulatory ,… more
- J&J Family of Companies (Danvers, MA)
- …dual-role position that combines field-based clinical research engagement, technical expertise in medical device support, and on call, bedside clinical support. ... and feedback ("Voice of Investigator") to Abiomed cross-functional partners such as R&D, medical affairs , marketing, sales, and education. JOB DUTIES + Provides… more
- Wolters Kluwer (Waltham, MA)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Abbott (Burlington, MA)
- …Software) or related discipline + Minimum of 5 years of R&D experience in medical device development and/or other highly regulated industry. (Advanced degree may ... integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs , and Regulatory Affairs . + Demonstrated leadership… more
- ConvaTec (Lexington, MA)
- …to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... full-time Convatec CSMs). **Principal Contacts & Purpose of Contact** Internal - Medical Affairs , Clinical Operations (Study Management, Site Management, Data… more
- Otsuka America Pharmaceutical Inc. (Concord, NH)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in in pharmaceutical quality, with specific ... or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Competencies** **Accountability for Results -** Stay focused… more
- PCI Pharma Services (Bedford, NH)
- …Responsibilities** Has overall responsibility for the PCI Pharma Services Quality Assurance and Regulatory Affairs programme in relation to D&M. Devise and drive ... vials, cartridges, and syringes. Quality experience in North America and Europe required. Medical device experience is a plus. Cross functional background is a… more