Regulatory Affairs Manager

X4 Life Sciences; Massachusetts; On-site; USD 120,000 - 125,000; Full time

Job summary

A leading company in medical device technology is seeking a Regulatory Affairs Manager in Massachusetts. The ideal candidate will have over 5 years of experience in regulatory affairs, particularly with 510(k) submissions, and will ensure compliance for products in both US and EU markets. The role involves preparing regulatory filings and collaborating with cross-functional teams to meet all requirements.

Qualifications

• Minimum of 5 years of experience in regulatory affairs for medical devices.
• Strong experience in 510(k) submissions.

Responsibilities

• Prepare IDE, 510(k), PMA, CE Mark, and other regulatory filings.
• Ensure regulatory compliance for products in US and EU markets.

Skills

Regulatory Affairs

Compliance

Documentation

Regulatory Frameworks

Job description

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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 [e-mail].

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

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