Regulatory Affairs Specialist - 14 month Fixed term

Fisher Paykel Healthcare; Howick; On-site; NZD 90,000 - 120,000; Full time

Job summary

Fisher & Paykel Healthcare is seeking a Regulatory Affairs Associate/Specialist for a 14-month fixed-term role. You will support global regulatory clearance and market access for medical devices, partnering with teams to drive efficient processes and faster approvals.

The role sits at Associate or Specialist level based on candidate skills, requiring a tertiary qualification in engineering/science/law and 3+ years in a regulated industry.

Qualifications

• Tertiary qualification in engineering, science or law.
• Solutions-focused attitude with a continuous improvement mindset.
• Methodical, analytical and strategic approach with strong attention to detail.
• Strong relationship-building skills capable of engaging and influencing stakeholders.
• 3+ years of experience in a regulated industry (medical devices, pharma, food, aviation).

Responsibilities

• Lead regulatory projects and set strategy for global market access.
• Identify opportunities to improve regulatory processes and drive efficiency.
• Collaborate with cross-functional teams across the business and external stakeholders.

Skills

Planning skills

Presentation skills

Analytical thinking

Relationship building

Strategic thinking

Attention to detail

Stakeholder influence

Education

Tertiary qualification (engineering/science or law)

Job description

Regulatory Affairs Specialist - 14 month Fixed term

Care to improve patient care around the world?

Join a team of good people doing good work with intent.People like you, who care to make a difference.

About the role

At Fisher & Paykel Healthcare we improve patient care and outcomes through inspired, world-leading healthcare solutions. As designers, manufacturers and marketers of innovative medical devices, we are required to comply with a wide range of country specific regulations and require market clearance prior to commercialisation for new and modified products.

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.

In this 14-month fixed term position as a Regulatory Affairs Associate/Specialist, you will support the global commercialisation of leading and innovative medical device products while also driving efficiencies in our regulatory processes. Partnering with teams across the business, you’ll identify opportunities to create and improve process change, enabling quicker market access for new and modified products.

We have flexibility in our role to modify it to sit either at Associate or Specialist level based on candidate skills level.

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 engineering, science or law.
• You will possess a solutions-focused attitude with a continuous improvement mindset
• You will have a methodical, analytical and strategic approach to your work together with a strong eye for detail.
• You will have strong relationship-building skills, capable of engaging and influencing key stakeholders
• You will have 3+ years' experience working in a regulated industry such as medical devices, pharmaceuticals, food manufacturing or aviation.

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.

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 [e-mail]