Regulatory Affairs Specialist

**About the Role**

As designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of standards, regulations and guidelines mandated by regulatory authorities.

Our Regulatory Affairs team is critical to our success ensuring that our devices are designed to meet regulatory requirements, are accepted in market, and remain so in the face of change. Our Regulatory Affairs team support the 120+ countries that we sell our products into and ensure that we remain competitive in obtaining and maintaining quick market access.

This is a 6 month fixed-term opportunity to work as a Regulatory Affairs Specialist supporting markets including China, Taiwan, Latin America, Southeast Asia, Africa, and the Middle East.

In this fixed-term role you will be at the forefront of ensuring regulatory compliance by:

- Conducting research to identify regulatory requirements, interpreting regulations and staying up to date with regulatory guidelines and requirements.
- Writing and communicating design control and regulatory strategy inputs to ensure that requirements and other regulatory intelligence is incorporated into design decisions, the products, and associated outputs.
- Collaborating with cross-functional teams such as Design, Quality and Marketing and acting as an interface to provide guidance on regulatory and compliance matters to ensure products meet regulatory requirements and standards.
- Interacting with regulatory bodies, managing relationships with regulators and being able to communicate and present technical elements in a way that the regulator can understand.
- Managing a regulatory dossier including regulatory submissions, filings, and approvals, ensuring documentation is fit for purpose, meets regulatory requirements and approved for release.
- Adapting to the constant change in the regulatory environment and conducting regulatory impact assessments to identify potential issues and develop mitigation plans for any changes that might have an impact on the business.
- Resolving regulatory issues and identifying opportunities for improvement by problem solving and collaboration with cross functional teams such as the Supply Chain and Quality Distribution.

**About You**

Attitude is all-important with this role, and you will be driven to get stuck in to help achieve team plans. Working with systems and processes and utilising your planning and presentation skills will enable you to successfully lead projects, set strategy and build strong relationships within the company and with external stakeholders.
- You will be tertiary qualified, preferably in Law, BioScience, Engineering, or Science.
- You will have 4+ years' experience working in a regulated industry such as, medical devices, pharmaceuticals, automotive, food manufacturing or aviation, or within a regulatory body with a relevant Regulatory Affairs Certification being highly desirable.
- You will have a strong eye for detail, complemented by your methodical, analytical approach.
- You will be fluent in English, and able to evaluate, summarize and clearly communicate market requirements to the New Zealand based team.
- You will demonstrate strong leadership skills with prior experience in customer relations, managing and organising people.
- You have a continuous improvement focus and a solutions-oriented attitude, enabling you to think outside the box and work with rigour to lead improvements to our regulatory processes.

**Working With Us**

Care to join a supportive environment?**Fisher & Paykel Healthcare foster an inclusive work environment founded on our culture of care and cooperation. Here you’ll have the trust and support to generate ideas, solve problems and do your best work.

**About Us**

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

Our commitment to care unites us. Here, we’re driven to improve patient care and outcomes through inspired and world-leading healthcare solutions.

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.

We are dedicated to designing our recruitment process with care and empathy
- Requisition ID: _5561_
- Posting end date: _28/05/2025_