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1 week ago Be among the first 25 applicants Direct message the job poster from X4 Life Sciences Empowering Digital Health & Medical Device Organizations Across the US | Engineering (Software, Mechanical) Quality Assurance, Regulatory Affairs. Regulatory Affairs Manager X4 are partnered with a highly regarded global medical device company known for its leadership in developing advanced technology that addresses serious medical conditions with precision and efficiency. Their commitment to excellence ensures that life-saving treatments are accessible to more hospitals worldwide. We are currently seeking a Regulatory Affairs Manager with a minimum of 5 years of experience to join their team in Massachusetts. This role is ideal for someone with experience in the regulatory landscape for medical devices, specifically in the context of high-tech capital equipment, and a strong track record in handling 510(k) submissions. Key Responsibilities: Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings Ensure regulatory compliance for products in both the US and EU markets, collaborating with cross-functional teams to meet all requirements. Work closely with the product development and clinical teams to ensure products meet all regulatory standards and guidelines. Develop and maintain comprehensive regulatory documentation, ensuring all processes are accurate and up-to-date. Monitor and stay informed about regulatory changes in key global markets, advising the team on strategies for entering emerging markets, including those in APAC. Qualifications: Minimum of 5 years of experience in regulatory affairs for medical devices. Strong experience in 510(k) submissions Background in regulatory affairs for capital price equipment such as MRI/CT scanners, surgical robots, radiation therapy equipment, or similar advanced technologies. Experience working with US and EU markets is essential; experience with APAC and emerging markets is a strong plus. Strong knowledge of regulatory frameworks for medical devices, including FDA, CE marking, and international standards. Experience with IEC 60601 and IEC 62304 standards is a bonus, though not required. If you are interested, or know anyone who is, please reach out to o.archer@x4lifesciences.com. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Health Care Provider, Quality Assurance, and Science Industries Medical Equipment Manufacturing and Staffing and Recruiting Referrals increase your chances of interviewing at X4 Life Sciences by 2x Get notified about new Regulatory Affairs Manager jobs in Massachusetts, United States . Sr Regulatory Affairs Specialist--Remote Senior Manager, Regulatory Affairs, Operations Boston, MA $120,000.00-$125,000.00 2 weeks ago Massachusetts, United States $63.00-$63.00 1 day ago Associate Director, Regulatory Affairs CMC Senior Manager, Regulatory Affairs Device Associate Director, Global Regulatory Affairs Regulatory Affairs CMC Specialist - Contract Bedford, MA $180,000.00-$200,000.00 1 week ago Senior Regulatory Affairs Specialist / Regulatory Affairs Manager Senior Regulatory Affairs Specialist / Regulatory Affairs Manager (994) Westford, MA $97,300.00-$194,700.00 2 months ago Manager, Global Regulatory Affairs, Marketed Products Boston, MA $111,800.00-$175,670.00 3 weeks ago Senior Manager, Regulatory Affairs (Clinical) Manager, External and Regulatory Affairs Vice President of Regulatory Affairs, Tempero Bio Boston, MA $130,000.00-$180,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr