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 [email protected].