- 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
- Abbott (Santa Clara, CA)
- … regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications ( FDA and international regulatory agencies) to ... imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …requirements. + Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . Assist in the collection of regulatory ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- Danaher Corporation (Deer Park, IL)
- …or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory strategy… more
- GE HealthCare (Chicago, IL)
- … requirements for product launch, premarket submissions/registrations and post-market compliance , working closely with healthcare regulatory bodies globally. ... requirements for product launch, premarket submissions/registrations and post-market compliance , working closely with healthcare regulatory bodies globally.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …team, you'll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards ... timelines + Ensure effective and timely execution of regulatory filings in compliance with relevant ...orphan products, fast track, breakthrough therapies, PRIME) + Strong FDA and EMA experience required + Full functional knowledge… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...+ Review/provide input into lifecycle management plans to ensure compliance with regulation + Monitor EVMSs appropriate for pharmaceutical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …(eg, FDA Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive ... RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs/ Compliance experience in medical devices + Experience with end-to-end SAMD new… more
- Actalent (Bowling Green, OH)
- …fast-paced environment, this is your moment. What You'll Own: + Lead regulatory compliance for a diverse portfolio: cleaning chemicals, coatings, equipment, ... Chemical & Product Manufacturing | Leadership Role | Global Compliance Are you a regulatory power house...safety. If you know your way around OSHA, EPA, FDA , DOT, REACH, and more, and you're ready to… more
- Stryker (San Jose, CA)
- …be provided. **Key Areas of Responsibility:** + Ensure divisional achievement of quality, regulatory , and compliance targets + Direct activities to ensure new ... desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements +… more
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