- 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
- CorDx (Atlanta, GA)
- …field; advanced degree preferred. Minimum of 7-10 years of experience in regulatory affairs within the medical device industry. Proven track record of ... in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta,...play a crucial role in leading and managing the regulatory submissions for CorDx medical device… 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
- 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)
- …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
- Lexington Medical (Bedford, MA)
- … Affairs , or other technically related field. 5-8+ years of experience in medical device regulatory affairs , including prior 510(k) submission and ... in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and...expansion. This is a terrific opportunity for an experienced medical device regulatory professional to… more
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry 2+ years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe, ... and international medical device regulations Experience drafting regulatory submissions for...certification or Advanced Degree (Masters in Regulatory Affairs ) Previous experience with Class II/III medical … more
- Medtronic (Irvine, CA)
- …of relevant experience Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs This is not a remote position ... Nice To Have 4 years of experience in medical device regulatory affairs Excellent technical knowledge of medical products and understanding of… more
- Johnson and Johnson (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Affairs ... Job Description: Johnson and Johnson is currently seeking a Medical Director, Medical Affairs , Orthopedics...cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics… more
- Cleerly (Denver, CO)
- …as a medical device (SAMD) Minimum 7 years of medical device experience in a regulatory affairs role. Experience in global regulatory ... and are a growing team of world-class engineering, operations, medical affairs , marketing, and sales leaders. We...changes, particularly for AI/ML standards and Software as a Medical Device (SaMD) regulations. Regulatory … more
- Capstan (Santa Cruz, CA)
- …BS Degree in a scientific discipline; MS degree is a plus. Minimum of 8 years of regulatory experience in the medical device industry; 6 years with a Masters ... Reports to: Head of Regulatory Affairs (SVP, RA) Workplace type:...meaningful impact for patients. We offer outstanding benefits with medical , dental, and vision covered at 100% for you… more
- IntePros (Audubon, PA)
- …looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs Associate ... Experience should demonstrate dependability, flexibility and attention to detail. Regulatory Affairs Associate Job Requirements: Under supervision of… more
- Abbott (Minneapolis, MN)
- …microbiology, etc.), math, engineering, or medical fields. Master's degree in Regulatory Affairs . Regulatory experience with capital equipment including ... get on with their lives. The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN.… more
- Intuitive (Sunnyvale, CA)
- …or in a Science field Experience: Minimum 3 years relevant experience working in a medical device company (can be in combination with a regulatory degree; ... Company Description Job Description New Product/Indication Submissions Provide regulatory insight to development, new product introduction, and manufacturing teams… more
- Prismatik (Irvine, CA)
- …in related field preferred Minimum five (5) years of experience in Regulatory Affairs . Experience in preparing (writing) domestic and international product ... and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US,… more
- Tandem (San Diego, CA)
- …product launch and post market compliance, working closely with healthcare regulatory bodies globally. Interprets Medical Device regulations, ... at https://www.tandemdiabetes.com/ A DAY IN THE LIFE: The Sr. Regulatory Affairs Specialist II is responsible for...regulations is desirable. 7+ years of related experience in regulatory function in medical device … more
- Globus Medical (Audubon, PA)
- …in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. Excellent ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. Position Summary : The Regulatory Affairs Associate assists in drafting, submitting… more
- Cedent (Boston, MA)
- …, clinical research, or a related area within the pharmaceutical, biotech, or medical device industries. Familiarity with regulatory submission processes and ... Overview: We are seeking a detail-oriented Regulatory Associate to join our Regulatory Affairs team. In this role, you will play a vital part in supporting… more
- Noah Medical (San Jose, CA)
- …Design History Files and support both internal and external audits. Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. ... and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement...of Engineering work experience with a BS in the medical device or similarly regulated industry or… more
