Fisher & Paykel Healthcare is looking for a Quality & Regulatory Associate to join our Post-Market Surveillance team on a 6-month fixed-term contract. You will be integral to monitoring our products in the global market, ensuring they remain safe and effective while driving continuous improvement across the business.
What You'll Do
- Analyse product surveillance feedback to identify areas of continuous improvement.
- Report to numerous international regulatory bodies to maintain compliance and limit regulatory risk.
- Coordinate international risk evaluations and field actions to ensure products continue to be safe and effective.
- Build relationships with all areas of the business, including executive management, marketing, sales, product development, manufacturing, and clinical.
- Regularly liaise with international regulatory bodies, such as the Food and Drug Administration (FDA) in the USA.
What We're Looking For
- Tertiary qualification in health sciences, engineering, law or business.
- Strong attention to detail.
- Excellent written and verbal communication.
- Effective interpersonal skills.
- Strong analytical skills.
- Inquisitive nature.
- Demonstrated influencing skills.
- Risk assessment experience.
Nice to Have
- Experience in Post Market Surveillance, Quality or Regulatory Affairs would be highly regarded.
Team & Environment
You will be part of the global Post-Market Surveillance team within the Quality & Regulatory department. Our culture is founded on a genuine care to find solutions, fostering an inclusive environment built on cooperation. We are a team of good people doing good work with the intent to improve patient care and outcomes through inspired and world-leading healthcare solutions.
Fisher & Paykel Healthcare is committed to providing an inclusive work environment.
