Quality Assurance Regulatory Affairs Manager

Key Responsibilities:

Quality Assurance:

Develop, implement, and maintain an effective QMS in accordance with applicable regulatory standards and guidelines.

Ensure ongoing compliance with QMS requirements through periodic reviews and audits.

Lead QA activities in company – R&D, Mfg., Engineering etc.

Lead QA processes in company – Investigations, MRB, PMS etc.

Regulatory Affairs:

Oversee the preparation and submission of regulatory filings, including 510(k) submissions, CE Marking, and international registrations.

Monitor changes in regulations and standards, assess their impact on the company, and develop strategies to ensure compliance.

Qualifications:

Bachelor's degree in a relevant field (e.g., engineering, life sciences).

Minimum of [3] years of experience in quality assurance and regulatory affairs management within the medical device industry.

Excellent communication and interpersonal skills.

Strong problem-solving and analytical abilities.