- Medtronic (Irvine, CA)
- …in sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the ... in internal and external audits as needed. + Maintain regulatory affairs documentation to support compliance with...not a remote position. **Nice To Have** + RAPS Professional Certification (RAC). + History of successful 510(k), IDE,… more
- Hologic (Louisville, CO)
- …product registrations. + Review labeling, marketing materials, and user manuals for compliance with US and international regulatory requirements. + Identify and ... Regulatory Affairs Specialist, International Marlborough, MA, United States...compliance issues. + Commitment to continuous learning and professional development. **Qualifications:** + Bachelor's degree in a technical… more
- Boehringer Ingelheim (Ridgefield, CT)
- …from various partners. + Handle the development of custom reports to support regulatory compliance and advise strategy. + Collaborate with partners to support ... supervision, the Fellow will: * Develop, compile, and integrate regulatory intelligence from health authorities, professional groups,...any compliance and process initiatives. + Own the review and… more
- UGI Corporation (Denver, PA)
- Sr Manager - Regulatory & Plant Accounting Location: Denver, PA, US, 17517 Workplace Environment: Hybrid Company: UGI Utilities, Inc Requisition Number: 27254 At UGI ... Lead the UGI Utilities and UGI Energy Services Accounting Departments through regulatory filings and manage the Plant Accounting department functions. Duties and… more
- Takeda Pharmaceuticals (Boston, MA)
- …manufacturing sites and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with global regulatory ... in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory … more
- City National Bank (Jersey City, NJ)
- …in a fast-paced, dynamic regulatory environment. * Experience in IT Risk, Regulatory Compliance , GRC or Internal Audit, ideally within a top tier financial ... *DIRECTOR OF AUDIT- IT REGULATORY ISSUES MANAGEMENT* WHAT IS THE OPPORTUNITY? The...reports under tight timelines. * Escalate roadblocks, delays, or non- compliance to appropriate governance bodies and drive resolution. *Review… more
- Kelly Services (Anaheim, CA)
- …products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing ... **Director of Quality and Regulatory Affairs** Kelly(R) Science & Clinical is seeking...complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with… more
- Beth Israel Lahey Health (Boston, MA)
- …just taking a job, you're making a difference in people's lives.** The Sr. Regulatory Specialist supports regulatory compliance for clinical research at Beth ... data, violations, deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when issues are… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject… more
- Gilead Sciences, Inc. (Washington, DC)
- … regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with ... regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global… more