Experienced Regulatory Manager & Technical Advisor required for an internationally successful NZ-owned medical devices company in Wellington.
- Broad spectrum regulatory/R&D role
- Innovative NZ medical devices company for the global market
- Join a small, dynamic, and growing team
Our client is a New Zealand owned company in Wellington. This small but innovative company manufactures medical devices for domestic and international markets. They are experiencing growth and expanding their customer base overseas and this is an exciting opportunity to join them in a management position and be part of that growth.
You will be working in a fast paced, constantly changing, high growth environment and be part of a small and growing team that is results focused. In this interesting and diverse role, you will be responsible for providing technical and scientific help and advice to the team in all aspects including regulatory, quality, research and IP related processes. You’ll be expected to ensure the regulatory compliance is maintained for the required regulations and manage regulatory requirements for global markets. As such you will be reviewing regulatory requirements, compiling export documentation, and responding to compliance and technical queries. You will also help oversee and progress the company’s R&D pipeline.
This dynamic business requires someone with equal dynamism. You’ll need to work independently but collaboratively with your colleagues and those regulatory agencies around you, be an excellent communicator, and have experience in the preparation and submission of regulatory agency applications, reports, or correspondence. In addition, you will also have experience working in a research orientated business to help progress a pipeline of new products.
In addition, you will ideally you will have:
- Tertiary qualification in a relevant scientific field
- 5 years pharmaceutical/medical device industry experience in a regulatory affairs function
- Experience with FDA, TGA, CE mark, and MDSAP
- Knowledge of international regulatory systems for Medical Devices
- Strong technical writing and analytical skills
- Ability to be flexible and versatile to respond to a variety of activities
- Ability to make risk-based decisions for regulatory compliance
- Strong communication and interpersonal skills
- A background in research and development
- Ability to train others and supervise where necessary
This is a rare opportunity to join an innovative NZ company delivering to a global market. You’ll join a team of hard-working and supportive people, and you will be able to make an impact as a Regulatory Manager in a small but growing company. You’ll have a competitive remuneration package, and a varied and challenging role to keep you engaged.
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Alternatively, for a confidential enquiry contact Olivia Lawrence on 04 916 0536 or firstname.lastname@example.org