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Regulatory Director
Amicoat AS
- Frist 1.10.2024
- Ansettelsesform Fast
Do you want to be at the forefront of medical innovation and contribute to reducing healthcare-associated infections?
Amicoat is expanding and seeking a Regulatory Director to strengthen our team at our site in Asker. We are passionate about reducing healthcare-associated infections (HAI) in a sustainable fashion. Our antimicrobial technology is inspired by Nature’s own defense against infections and has the potential to reduce HAI which can save both lives and hospitalization time, and is the result of decades of research performed at UiT the Arctic University of Norway. Our solutions can also reduce the need for treating HAI with antibiotics and are more sustainable than current antimicrobial technologies such as silver and antibiotics. If you want to be part of our journey and get our technology into next generation medical devices, this is a great opportunity. This role reports to the VP Business Development.
What will you do?
- Support and collaborate closely with our partners in approving their medical device products through the regulatory approval bodies in key strategic markets
- Organize and develop existing API documentation to meet the requirements and comply with regulations for medical devices in key markets
- Be responsible for and update our Drug Master File (DMF) to support our partners in their filing processes
- Maintain and further develop our Quality Management Systems (QMS)
- Depending on your experience and skills, you may be appointed responsible for chemical manufacture and control (CMC) for our API
- Be Amicoat's lead in customer audits and lead our supplier audits
What do you need to succeed?
To succeed, you need to be motivated and skilled in working cross-functionally in an innovative environment. You should enjoy a fast-paced environment where you frequently will be faced with big and small challenges within and outside your primary scope of responsibility. Furthermore, you should enjoy taking on big responsibilities while efficiently collaborating with other team members and stakeholders, both within and outside the company.
Required qualifications and skills:
- University degree within the life sciences (e.g. pharmacology, chemistry, biology, medicine)
- 5+ years of experience in regulatory affairs, market access, or quality assurance within the Medical Device, MedTech, or pharmaceutical industries
- Theoretical and practical knowledge with regulatory approval processes for medical devices or pharmaceuticals in key markets (e.g., FDA, MDR/MDD, EMEA, IVDR…)
- Experience with Quality Management Systems (QMS)
- Fluent in English and preferably in a Scandinavian language
Desired experiences and skills:
- Relevant experience in the Medical Device industry is highly meritorious
- Experience working in cross-functional teams
- Strong communication skills, including writing and presenting
- Working experience in quality assurance and quality control (QA/QC)
What do we offer?
- Be part of our journey in bringing Amicoat’s technology into products that make a difference
- Be a part of a small and highly skilled, interdisciplinary team
- Modern office and lab
- Supported on the job development
- Competitive compensation
- This role will be based in Asker
Ready to join us? Apply now and be a part of our innovative team!
Om arbeidsgiveren
About Amicoat
Amicoat AS is a Norwegian biotechnology company that discovers, develops, and commercializes novel antimicrobial science with broad applications across diverse industries. Our current focus is on medical devices, and we are also exploring utilization of our technology in other industries. With our origins above the Arctic Circle in the city of Tromsø in Northern Norway, we aspire to be a leading company in the antimicrobial coating industry, providing our clients with tailored antimicrobial coating solutions. Currently, Amicoat has 9 employees and is located in Asker.
- Nettverk: LinkedIn
- Sektor: Privat
- Sted: Hagaløkkveien 26, 1383 Asker
- Bransje: Farmasi og legemiddel, Helse og omsorg, Medisinsk utstyr og rekvisita
- Stillingsfunksjon: Helsepersonell, Kvalitetssikring, Prosjektledelse
- Arbeidsspråk: Norsk, Engelsk
Nøkkelord
medtech, regulatorisk direktør, kvalitetsstyringssystem, medisinsk teknisk utstyr, innovasjon
- FINN-kode 368928421
- Sist endret
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