We are looking for a highly skilled individual to assist the quality management and touchpoints with regulatory bodies across various business units or subsidiary companies with a specific focus on Europe and other regions.
Responsibilities
- Establish and maintain Quality System requirements effectively.
- Collaborate with junior peers to set and achieve quality and regulatory goals.
- Assist in preparations and negotiations with regulatory agencies for new markets and act as a contact for existing markets.
- Ensure business teams consider the impact of current or emerging quality and regulatory issues.
- Provide regulatory training and mentoring to staff across various departments.
- Explain audit findings, resolve conflicts, and consult on corrective and preventative actions.
- Interface with Regulatory Agencies during inspections.
- Represent the organization during regulatory and client inspections/audits.
- Prepare site/operation personnel for regulatory audits and create summaries and reports of such audits.
- Track corrective actions and update management on their status.
- Perform general auditing duties to ensure compliance with quality standards.
- Assist in the final review and management of SOPs and QM-related documents.
- Assist with Vendor Assessment, client audits, and subcontractor audits.
- Manage Technical Documentation for submissions and product changes.
- Optimize Quality and Regulatory processes and ensure global QA RA compliance.
Requirements:
- Degree in engineering, biomedical, or a related field; a Master's degree or MBA is a plus.
- 4+ years of experience in quality management and regulatory affairs for medical devices.
- Proven experience handling submissions, technical documentation, and the approval process (MDD / MDR / De Novo or 510(k)).
- Specialist knowledge of medical device QMS (ISO 13485 / 21 CFR 820).
- Experience managing external audits with notified bodies and competent authorities.
- Experience in risk management of medical devices as per ISO 14971 and implementing various medical device standards.
- Knowledge of standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series, and conducting Post Market Surveillance activities is advantageous.
- Coaching and mentoring skills.
- Fluency in English and B2 level of German.
- Flexible, goal-oriented, and a team player.
