Regulatory & Quality Manager

Our client is a small Medical Device manufacturer based in Tuttlingen. They are looking to strengthen their RA & QA department to keep all new and existing medical device products compliant with the new MDR as well as bringing new innovative products to market. The role will cover products in all lifecycle stages, from early design to well-established products.

Responsibilities

• Maintain compliance of all products will relevant regulations (EU MDR, FDA and others)
• Write and submit CE markings and relevant 510k documentation, as well as perform gap analysis for regulatory compliance.

• Maintain & update the QMS and oversee its implementation.
• Validation of new products and changes to existing products.
• Follow-up and investigation of non-conformities.
• CAPA initiation, investigation and if needed execution of corrective and preventive actions.

• Drive expansion into new international markets.
• Lead Post Market Surveillance and assessment of changes.
• Support Notified Body submissions and audits.

Requirements

• Ph.D. or master’s degree in relevant background
• At 2-5 years’ experience in Medical device regulations (MDD and MDR), including experience in Class 2b and 3.
• Experience with regulatory filings (technical documentation for CE-certification)
• In depth knowledge MDR 2017/745, 21 CFR Part 820 and maintaining a company QMS (ISO 13485, ISO 14971, etc.).
• Knowledge of IVDR 2017/746 is an advantage.
• Regulation experience through full device life-cycle with relevant processes including risk management.