Head of Quality/Regulatory (Medical Devices)

Hobson Prior is seeking a Head of Quality/Regulatory for a role in the medical devices industry. This position focuses on ensuring the highest standards of quality and regulatory compliance for surgical equipment.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

Quality Assurance

1. Leadership : Oversee the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards and regulations.
2. Quality Control : Establish robust procedures for incoming, in-process, and final inspection of products.
3. Continuous Improvement : Drive quality improvement initiatives, including CAPA management, risk management, and root cause analysis.
4. Audits : Plan, execute, and oversee internal and external audits, including Notified Body, regulatory agency, and supplier audits.
5. Supplier Quality : Develop and maintain supplier qualification and monitoring programs to ensure raw material and component quality.

Regulatory Affairs

1. Regulatory Strategy : Develop and implement global regulatory strategies to achieve and maintain market authorizations, including CE marking, FDA 510(k)/PMA submissions, and compliance with regional regulations (e.g., MDR, TGA, ANVISA, etc.).
2. Documentation : Oversee preparation and submission of regulatory dossiers and technical files, ensuring timely approvals.
3. Compliance Monitoring : Stay up to date with regulatory changes and provide guidance on their impact to the business.
4. Labeling and Claims : Ensure compliance of product labeling, marketing claims, and instructions for use (IFU) with applicable regulations.
5. Regulatory Liaison : Act as the primary contact for regulatory agencies, Notified Bodies, and other external entities.

Team Management and Cross-Functional Collaboration

1. Build, mentor, and lead a high-performing Quality and Regulatory Affairs team.
2. Partner with R&D, Manufacturing, and Operations teams to ensure quality and regulatory considerations are integrated throughout the product lifecycle.
3. Drive a culture of quality and compliance across the organization.

Key Skills and Requirements:

1. Bachelor’s or master’s degree in engineering, Life Sciences, or a related field; advanced degree preferred.
2. German language is essential.
3. Experience in Quality Assurance and Regulatory Affairs within the medical device industry in a leadership role.
4. Proven experience with surgical equipment or Class II+ medical devices.
5. In-depth knowledge of global regulatory frameworks (e.g., FDA, EU MDR, ISO 13485, MDSAP, etc.).
6. Expertise in quality systems management, risk management (ISO 14971), and product lifecycle processes.
7. Strong track record of successful regulatory submissions and approvals.
8. Exceptional leadership, communication, and problem-solving skills.

For more information, please contact Toby Shelton .

Apply now

If you are interested in learning more or applying to this exciting opportunity, please click ‚Apply‘ and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please select ‚Contact me‘ at the top of this page.

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