Senior QA/RA Manager

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.