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.

Due to an internal move, we require a Regulatory Affairs Specialist to join one of our Regulatory Affairs teams supporting markets including New Zealand, Australia, India, Sri Lanka, Pakistan, China, Taiwan and Hong Kong.

In this 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**
- To be considered for this role, you will currently work in a regulated industry. And, you will enjoy performing detailed analysis and effectively communicating the big picture of what can be achieved through those insights._
- 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 experience with data handling, traceability records, uploading data into systems (such as SAP) and using data visualisation tools such as Power BI and Smartsheet.
- You will be proactive, responsive and effective in working at pace and reacting in real-time. You will have the ability to work across multiple cultures and time zones to enable international reach.
- 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.
- You will have a methodical, analytical and strategic approach to your work together with a big-picture mindset.
- You can build strong relationships with a variety of stakeholders to actively engage and influence outcomes and drive results.

**Benefits**
- Employee share purchase scheme
- Discretionary Bi-annual Profit share
- Annual Salary Review
- High rates of internal promotion
- 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
- Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
- Subsidised Cafés and free parking

**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 soc