- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...including drug device /combination products and software as medical device platforms.- Reviews and resolves issues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- VB Spine LLC (Allendale, NJ)
- …or related technical discipline Minimum 1 year of experience in medical device labeling and/or regulatory affairs Understanding of medical ... Regulatory Labeling Specialist Location : Leesburg, VA or...to ensure labeling accuracy, usability, and alignment with global medical device regulations. Candidates should ideally be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Medical Affairs , Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated ... Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... go-to-market plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related… more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work… more
- University of Utah (Salt Lake City, UT)
- …a 9-month (annually Aug. 16 - May 15) Career-line faculty position in the area of Regulatory Affairs , Medical Device Design and Regulatory Science. ... and strong interest in teaching Regulatory Affairs , Regulatory Science, and medical device design courses. Practical experience in regulatory … more
- Atrium Medical (Hudson, NH)
- …internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs ... the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations. Participates… more
- Masimo (Irvine, CA)
- …the incumbent will be a key person in making it happen. The incumbent's medical device regulatory expertise, organizational ability, and multi-tasking skills ... Description Job Summary In this high profile role, the Regulatory Affairs Specialist I will be an...software or electronic device products; Knowledge of regulatory submission requirements for FDA Class II medical… more
- Abbott (Santa Clara, CA)
- …international requirements for our medical devices. This role requires background in regulatory affairs and experience with labeling from a regulatory ... from a regulatory perspective. Strong knowledge of regulatory requirements for medical device ...device portfolio. Label Design and Development: Collaborate with Regulatory Affairs specialists, international regulatory … more
- Katalyst HealthCares and Life Sciences (Baltimore, MD)
- Responsibilities : Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed ... Review and approve labeling, training, promotional, and advertising material. Maintenance of Regulatory Affairs product files and ensure compliance with … more
- Foresight Diagnostics (Boulder, CO)
- …the ability to work collaboratively in a cross-functional environment. *Familiarity with medical device regulatory pathways and requirements. *Ability to ... Foresight Diagnostics is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product… more
- Intuitive (Sunnyvale, CA)
- …Experience Minimum 3 years RA experience is required. Demonstrated understanding of NMPA medical device regulatory requirements, China GB/YY standards, Hong ... and other cross-functional supporting teams to ensure the company's regulatory affairs activities are conducted in accordance...as well as fundamental US FDA requirements posed on medical device . Experience with new product development… more
- Abbott (Alameda, CA)
- …Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in ... diversity, working mothers, female executives, and scientists. The Opportunity This S enior Regulatory Affairs Manager - APAC position will work on-site at our… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...deadlines in a timely manner. Experience working in the Medical Device industry. Certification is a plus… more
- CryoLife (Kennesaw, GA)
- Company Overview: Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that ... information about Artivion, visit our website, www.artivion.com. Position Overview: The Regulatory Affairs (RA) Specialist is responsible for supporting… more
- Synectics Inc (Dublin, CA)
- …Strong knowledge of regulatory requirements and quality standards for medical device manufacturing. Excellent project management and organizational skills. ... to join our team and oversee the transfer of medical device manufacturing processes from one facility...Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs , and Supply Chain, to align… more
- LanceSoft (Dublin, OH)
- …*Must be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing ... all quality, quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirements. Read and/or understand operating procedures for… more
- AbbVie (North Chicago, IL)
- …Safety, Medical & Regulatory Quality is part of the R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight of AbbVie's ... standards, worldwide regulatory requirements and industry best practices relating to Medical Affairs and RWE generating activities. Flexibility to adapt to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU)...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
