Head of Quality and Regulatory Affairs
We seek a dedicated, passionate and hardworking individual who will bring experience, unique perspectives and problem-solving skills to our team. In return, you will be part of a highly skilled EpiGuard team that offers a dynamic and motivational environment and ability to impact our success in the future. We will launch our product in several new markets and expand our product portfolio in the future. If you want to be a part of this journey, please apply to our position.
The person we are seeking will have overall responsibility for all Quality and Regulatory Affairs at Epiguard AS. Our head of Quality and Regulatory Affairs will be:
- Responsible for Regulatory affairs, as per MDR article 15.
- Appointed Risk Manager, as per ISO14971:2019
- Management representative as per ISO13485:2016 section 5.5.2. We are in the process of getting ISO 13485 certified.
- Responsible for maintaining and improving the Quality Management System, including key quality processes such as CAPA, internal audit, supplier management, nonconformances, analysis of data, etc.
- Main responsible for compilation, submission and maintenance of EpiGuard technical files along with EpiGuard CTO and R&D department.
- Responsible for development of regulatory strategy documenting the most suitable pathway for regulatory approvals, including Europe, US, Japan and Canada, in addition to future potential new markets.
- Regulatory Affairs Subject Matter expert
- Responsible for interaction with notified bodies and national health authorities
Head of Regulatory and Quality Affairs will collaborate with cross-functional partners such as R&D, Operations, Marketing to seek their input into the development of policies and procedures. The role will also ensure promotion and awareness of applicable regulatory and QMS requirements throughout EpiGuard, to ensure that all employees, including suppliers working directly within the QMS, are aware of the requirements as well as the consequences of noncompliance.
- Relevant education degree (B.Sc. or M.Sc.) or equivalent in relevant scientific discipline, healthcare professional or similar.
- Preferably 5 years of experience in relevant positions. Minimum 1-year hands-on experience with both Quality and Regulatory Affairs in related field.
- Strong knowledge of directives, standards, and guidelines within the medical device industry
- Having experience within International registration applications would be an advantage.
- Strong understanding of regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO13485
- In-depth understanding of the application of quality systems to the medical device industry.
- Interest and ability to learn and configure eQMS system - MasterControl and become the system administrator.
- Structured and effective with an analytical and professional approach.
- You are detail-oriented and capable of digesting large amounts of complex data but have the ability to be flexible with changing priorities.
- A strong collaborative approach towards stakeholders and enjoy working in cross-functional teams - R&D, quality, clinical, etc.
- You have excellent written and verbal communications skills and have submission-related word processing skills.
We can offer varied, exciting and challenging tasks in an innovative start-up company. You will work hands-on with new and life-changing technology, in a role with a lot of responsibility with the ability to make a real difference in the company. Travelling abroad will be required from time to time. The position is based in Oslo and will report directly to the CEO.
EpiGuard is a Norwegian company established in 2015 by a group of doctors at the Oslo University Hospital, together with co-founders Inven2, Eker Group, and Hansen Protection.
The company holds top level expertise with product development and manufacturing. The medical background ranges from intensive care, infectious diseases, internal medicine, and anesthesiology, through to transport medicine.
Our first product is the EpiShuttle, which was developed by clinical experts with first-hand experience in providing advanced treatment and transportation of patients with highly infectious diseases, including Ebola. We aim to continue to develop and manufacture high-end medical equipment for safe transport of contagious patients.
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