Fisher & Paykel Healthcare, Inc. Regulatory Affairs Manager - US 510(k) Expert in New Zealand

About Us

With over 3000 employees working across 26 countries, Fisher & Paykel Healthcare is one of the most well established and innovative companies in New Zealand. Fisher & Paykel Healthcare are world leaders in the design and manufacture of medical devices for the treatment of Sleep Apnoea, Respiratory & Acute Care and Surgical Humidification.

Our Regulatory Affairs team is critical to our success by ensuring we can obtain and maintain global market access for our great products.

About the Role

Our company is growing and the Regulatory Affairs team is growing alongside it. This growth has resulted in a newly created position for a Regulatory Affairs Manager with sound experience working with US 510(k) and/or PMA submissions. This manager will support one of our product groups as well as being the company expert overseeing our 510(k) submissions. An important aspect is driving change and reducing 510(k) submission times across the wider business.

About You

With four to five years of regulatory experience in the medical device industry and experience in leading a team, you'll be looking for an opportunity to take your career to the next level. We're particularly interested in your 510k submission experience in Class >II (US Classification) equivalent medical devices and/or PMA submissions.

You are passionate about the contribution you make to a business and understand how important it is to provide an exceptional level of service. You are a leader that enjoys coaching and developing your team and can also build strong relationships across the business as well as effectively manage change.

We truly believe we offer a unique opportunity to develop your regulatory career. And you will also join a company that values work/life balance, provides great benefits and has an open and friendly team culture.

If this role looks like the next step in your regulatory career, then please apply now!

Reference #: 42821

Posted on: 29 Jun 2017

Location(s): New Zealand

Expertise: Quality/Regulatory Affairs

Job level(s): Indirect