Quality and Regulatory Affairs Manager
About the Role
A critical need exists for oversight of the quality management system, audit preparation, and accompanying workload as we move forward.
We are looking for a highly skilled individual to oversee quality management and touchpoints with regulatory bodies across various business units or subsidiary companies with a specific focus on Europe, South Africa, and Australia. While this position will take a global oversight of our quality management and regulatory affairs, the ongoing proceeding with the FDA and future US dealings will not be in scope for this role.
We are targeting profiles that have a strong background in quality management and that have a demonstrated ability to collaborate with internal stakeholders, coach junior peers, and effectively manage external resources such as consultants and advisors.
Responsibilities
- Ensure that applicable Quality System requirements are effectively established and maintained.
- Lead preparations and negotiations with regulatory agencies/authorities new markets while acting as a primary point of contact for regulatory authorities in existing markets.
- Ensure business teams consider the impact of current or emerging quality and regulatory issues.
- Ensure staff receives appropriate regulatory training and mentoring to enable the execution of regulatory responsibilities across various departments.
- Explain audit findings, resolve conflicts, and consult on corrective and preventative actions if issues arise.
- Interface with Regulatory Agencies during inspections.
- Represent the organisation during regulatory and client inspections/audits.
- Prepare site/operation personnel for regulatory audits and prepare appropriate summaries and reports of such audits.
- Track corrective actions and apprise management of their status.
- Perform general auditing duties for compliance with quality standards.
- Be responsible for the final review and management of SOPs and QM-related documents.
- Assist with Vendor Assessment, client audits and subcontractor audits.
Requirements
- Degree in engineering, bio medical or similar would be necessary, Masters degree or MBA is considered a plus.
- 5+ years of relevant experience in quality management and regulatory affairs for medical devices.
- Specialist knowledge of ISO 13485 and medical device regulations is mandatory.
- Experience in managing external audits with notified bodies and competent authorities as per ISO 13485 & MDR.
- Experience in risk management of medical devices as per ISO 14971.
- Fluency in English and B2 level of German is required.
- Flexible, goal oriented and a team player would be an ideal candidate.