- Novo Nordisk Inc. (Plainsboro, NJ)
- … and content, and field alignment directors. They will also be the senior strategic representative of medical affairs in the relevant therapy area for all other ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...team and other relevant functions As a senior level representative of medical affairs , the TA head… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... data for purposes of assessing market access trends, hub program utilization, and performance against defined KPIs Function as...and patient access Customer Support Acts as a key representative of Novo Nordisk, on behalf of Patient Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST leader… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... This position does not have any direct reports.ResponsibilitiesResponsibilities: Additional representative responsibilities will include, but not necessarily be limited… more
- Novanta Inc. (Sarasota, FL)
- …of cooperation with the departments: Purchasing/ Service/ Production/ QM/ Manufacturing Engineering/ Regulatory Affairs / PM and with customers as well as ... project management of a new medical device as part of bigger development program . The role covers typical tasks and responsibilities of project management like… more
- Catalent Pharma Solutions (Bloomington, IN)
- **We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!** Catalent is a global, ... to help people live better, healthier lives. The **Senior Regulatory Affairs Specialist** serves as the liaison...+ Competitive salary with bonus potential. + Tuition reimbursement program . + Diverse, inclusive culture. + Generous 401K match.… more
- University of Washington (Seattle, WA)
- …beauty. **UW Medicine has an outstanding opportunity for a Director of Clinical Regulatory Affairs and Associate General Counsel to join their team.** **GENERAL ... DESCRIPTION AND PURPOSE** The Director of Clinical Regulatory Affairs (Director), Associate General Counsel for UW Medicine Nonprofit Entities and CUMG (AGC) has… more
- Medtronic (Santa Rosa, CA)
- Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid) Come be a part of one of the most exciting therapy areas ... this need, we are adding to our world-class M&T Regulatory Affairs team and looking to hire...discussions in an effort to support creative and compliant regulatory strategies for the program . + Partners… more
- Stryker (Portage, MI)
- …onsite role based in **Portage, Michigan.** **What you will do** **The Manager, Regulatory Affairs , State Licensing, Designated Representative ** works with a ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- Randstad US (Chicago, IL)
- …responsibilities: The Regulatory Affairs Specialist will be the regulatory representative for assigned due diligences, under the direction of the ... global regulatory affairs strategist. + chicago ,... recommendation. In addition, you may be an assigned regulatory representative for a product/s within a… more
- Philips (San Diego, CA)
- …Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and ... internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with global team… more
- Amazon (Bellevue, WA)
- …process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs , and internal auditors. Our mission is ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...medical devices. Key job responsibilities * Acts as a regulatory representative on core product development teams,… more
- Abbott (Atlanta, GA)
- …female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart Failure Division. As ... an individual contributor, the Principal Regulatory Affairs Specialist is...geographies. **What You'll Work On** + Acts as a regulatory representative on core product development teams,… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Regulatory Affairs Specialist II** to join our team on-site in Plymouth, ... reviews and approves engineering changes. + Acts as a regulatory representative responsible for review and analysis...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Proficient with… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: ... Master's degree in Regulatory Affairs or related field plus 2...EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up… more
- Veterans Affairs, Veterans Health Administration (Manchester, NH)
- …may include planning, developing, and directing a prosthetic and sensory aids program . The Prosthetic Representative works with Veterans, caregivers, vendors, ... Summary The incumbent serves as a Prosthetic Representative (Service Chief) managing and supervising the full...projects, activities independently to meet PSASs long- and-short term program goals. Plans, develop, and directs a Prosthetic and… more
- ICP Group (Andover, MA)
- …Asia Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Manager. The PSRA Manager ensures that all product-related activities ... post-commercialization) are conducted in accordance with the current domestic and global regulatory statutes that govern the respective industries for ICP to meet… more
- Fresenius Medical Center (Waltham, MA)
- …of proposed product changes. + Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams. + Provides ... can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product… more
- Veterans Affairs, Veterans Health Administration (Tucson, AZ)
- …administrative activities are in compliance with agency and accrediting and regulatory requirements especially as they pertain to Patient Rights and ... This is not a virtual position. Position Description/PD#: Patient Representative /PD04364A Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI):… more
