Job Description

Job Title: Regulatory Affairs Specialist

Our client is seeking an experienced Regulatory Affairs Specialist to lead regulatory strategy and submissions for medical devices. This role involves ensuring compliance with global regulatory requirements, supporting product development processes, and driving successful market approvals. This is a great opportunity for a detail-oriented professional to contribute to the regulatory success of innovative healthcare technologies.

Key Skills:

• Proven experience in preparing and submitting regulatory documentation (e.g., 510(k), CE Marking, Technical Files) for Class II medical devices, including implants.
• In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and ISO 14971 .
• Strong expertise in regulatory compliance, risk assessment, and product lifecycle management.
• Excellent technical writing, organizational, and project management skills.
• Experience in regulatory interactions, submissions, and approvals in the US and international markets.
• Familiarity with medical device software regulations and design control (preferred).

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field .
• 3-5 years of regulatory affairs experience within the medical device industry.
• Experience working within 21 CFR 820, ISO 13485, and European Medical Device Regulation 2017/745 .
• Regulatory Affairs Certification (RAC) or equivalent credential (preferred).

This is an exciting opportunity to join a growing company in the medical device industry. The role offers the chance to apply your regulatory expertise in a dynamic environment, supporting the development of impactful healthcare solutions.

For immediate consideration, please apply. Alternatively, you can contact Scot Widjaja at (213)-262-2064.

Job Tags

Similar Jobs