Regulatory Affairs Senior Manager - Devices

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Responsibilities:

• Coordinate and lead internal and external audits, implement and maintain quality assurance programs, policies, processes, procedures and controls ensuring that the performance and quality of the products conform to established standards and agency guidelines.

• Design, implement, and improve company quality management systems for medical device companies (ISO 9001, ISO 13485, 21 CFR Part 820 and MDSAP)

• Overseeing all QMS issues and concerns by providing quality tools and direct support to the teams.

• Analyze data, keep records of quality reports, statistical reviews, and relevant documentation to improve production.

Qualifications

• Excellent knowledge of ISO 9001 and ISO 13485

• Experience in developing and maintaining QMS under ISO 13485:2016 and 21 CFR 820, GMP and MDSAP

• Experience gained in a clinical diagnostic laboratory, bringing diagnostic products to the market.

• Bachelor's degree in biology, chemistry or similar.