- Hologic (Marlborough, MA)
- Regulatory Affairs Specialist , International Marlborough, MA, United States Louisville, CO, United States **Join Our Team: Regulatory Affairs ... make a real impact in healthcare innovation? As a Regulatory Affairs Specialist supporting our...materials, and user manuals for compliance with US and international regulatory requirements. + Identify and recommend… more
- J&J Family of Companies (Raynham, MA)
- …States of America **Job Description:** We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our Spine group. _This role ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … more
- Hologic (Marlborough, MA)
- Regulatory Affairs Specialist , Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... Regulatory Affairs Specialist ** Are you...+ Understanding of ISO 13485, ISO 9001, FDA, and international regulatory requirements. + Data and statistical… more
- Philips (Cambridge, MA)
- …member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory ... visits by Notified Body. May represent Philips in an international committee chartered to develop an applicable standard. **You're...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- Philips (Cambridge, MA)
- **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory Affairs Specialist recommends process improvements, updates ... fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring SaMD or SiMD… more
- Medtronic (Boston, MA)
- …in a more connected, compassionate world. **A Day in the Life** Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs ... and approvals for international market access, ensuring alignment with international regulatory requirements (RF, non-medical and medical). In collaboration… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …problem solving, communication and writing skills, as well as knowledge of regulatory and industry compliance and accreditation issues. Duties for the position ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). SF-50, Notification of Personnel...more than one year old PLEASE CONTACT THE HR SPECIALIST LISTED ON THE ANNOUNCMENT IF YOU HAVE ANY… more
- Catalent Pharma Solutions (Chelsea, MA)
- …of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or 4 ... **Job Title:** Sr. QA Specialist , Operations **City:** Chelsea **State** : MA **JOB...various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of regulatory guidelines and compliance requirements relevant to medical affairs activities. + Proven leadership and people management skills and the ability ... excellence and support the medical strategy teams by providing specialist knowledge and capabilities to support the disease areas...and advance digital innovation and data analytics in medical affairs . Under the direction of this role, the teams… more