Post Market Surveillance Specialist
About The Role
As part of our commitment to ‘Care by Design’, our Quality and Regulatory business group is dedicated to improving patient care and outcomes.
Sitting within Quality, Safety and Regulatory, our global Post-Market Surveillance team drives this continuous improvement by monitoring the safety, performance, and quality of our products once they are out in the market. They raise awareness of any quality issues and manage regulatory compliance and risk across our global markets.
We have a unique opportunity for a motivated individual from a clinical, medical, pharmaceutical, engineering, or legal background to join our global PMS team as a Post Market Surveillance Specialist.
In this position, you will be responsible for analysing customer complaints and product feedback, liaising with international regulatory bodies, (such as the Food and Drug Administration (FDA) in the USA) and writing detailed reports to maintain compliance and limit our regulatory risk. You will also support any field actions to ensure our products continue to be safe and effective. You will build relationships with many areas of the business and regularly liaise with our global offices to support their post-market surveillance activities.
Skills & Experience
We are looking for someone with:
- A tertiary qualification in health sciences, nursing, pharmaceuticals, engineering, law, or business.
- A minimum of 3 years’ experience working in a quality and/or regulatory role, ideally within a regulated industry and with medical devices experience being highly advantageous.
- Strong attention to detail.
- Excellent formal writing skills and effective verbal communication with the ability to influence and persuade.
- Effective interpersonal skills with the ability to build strong relationships.
- Strong analytical and critical thinking skills together with an inquisitive nature.
- The ability to work autonomously and at pace.
- Risk assessment experience.
Benefits
- Employee share purchase scheme
- Bi-annual Profit share
- Generous Paid Parental Leave
- Life, Critical illness and Income Protection Insurance
- Discounted Health Insurance
- Active Social clubs & community groups
- In-house training programs from external providers
- Purchasing privileges for Fisher & Paykel Healthcare products
- School holiday programme subsidy
- Banking and Insurance discounts
- Free Parking
- Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
- Subsidised Café’s
- Annual Salary Review
- High rates of internal promotion
About Us
Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally. We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.
We focus on nurturing a positive and inclusive culture based on trust and respect. In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.
If you're seeking a role with endless opportunities to develop, grow and advance your career, then apply now!
We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you require support or adjustments during our process, please let us know at recruit@fphcare.co.nz.
Requisition ID: 3939
Posting end date: 20/10/2023