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Senior Quality and Regulatory Affairs Manager

About the Role

A critical need exists to assist the department of quality management and regulatory affairs and accompanying workload with junior peer as we move forward.

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, South Africa, and Australia.  

We are targeting profiles that have a strong background in quality management and regulatory affairs 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.
  • Work closely with your junior peer to establish and maintain quality and regulatory goals.
  • Assist preparations and negotiations with regulatory agencies/authorities’ new markets while acting as one of contacts 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 along.
  • Assist for the final review and management of SOPs and QM-related documents.
  • Assist with Vendor Assessment, client audits and subcontractor audits.
  • Management of Technical Documentation for submissions and product changes.
  • Assist in optimization of Quality and Regulatory processes and responsible for global QA RA compliance.

 

Requirements

  • Degree in engineering, biomedical or similar would be necessary, Master’s degree or MBA is considered a plus.
  • 4+ years of relevant experience in quality management and regulatory affairs for medical devices.
  • Prior proven experience of handling a submission, technical documentation, and the approval process (MDD / MDR / De Novo or 510(k)).
  • Specialist knowledge and application of medical device QMS (ISO 13485 / 21 CFR 820).
  • Experience in managing external audits with notified bodies and competent authorities.
  • Experience in risk management of medical devices as per ISO 14971. Interpreting and implementing various medical devices standards.
  • Knowledge of other standards for electrical testing, EMC testing (ISO 60601), or ISO 62366 series and conducting Post Market Surveillance activities would be advantageous.
  • Coaching and mentoring skills.
  • Fluency in English and B2 level of German is required.
  • Flexible, goal-oriented and a team player would be an ideal candidate.