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About the company

The company is active in the field of medical devices and is owned by an US company with high belief in the individual. The business is located in Upplands Väsby, northern Stockholm area, and employs 30 people. Focus is on research & development and production within biocompatible surface coatings with active pharmaceutical ingredients for blood contact applications. Commitment, work balance and continuous personal development are encouraged. The company is ISO 13485 certified.

Within the organization, we work in small teams with a high degree of individual freedom, in order to meet the set goals. The company is organized with one Country Manager and three functional leaders.

More detailed information on the company and the organization will be shared in the next phase of the recruitment process.
Sr. Regulatory Affairs Manager, lÀkemedel - TILLSATT
About the position - TILLSATT

The company is looking for an independent and experienced person with an interest in working for a small company with a high level of commitment.
In this position, you will be the expert in the field of regulatory affairs. The main technology is a surface coating with an API (Active Pharmaceutical Ingredient) component that needs to comply with regulations within the fields of medical devices and pharmaceuticals. Products with the technology are sold worldwide.
Commitments are highly variable and involves preparation and support of submission files for regulatory bodies within medical devices and pharma. It is important that you have an interest in communication and coordination since all documentation is prepared in collaboration with customers and suppliers.
Communication with regulatory consultants and authorities are also important.

Requirements and expected experience
The person we are looking for should preferable have:

-Knowledge of EU and International regulations related to pharmaceuticals and/or drug/device Combination Products with a device primary mode of action.
- Knowledge and experience in the Pharmaceutical and/or Biologics industry, especially related to Chemistry, Manufacturing and Controls (CMC).
- Be familiar with regulations pertaining to Material of Animal Origin.
- Worked with Active Pharmaceutical Ingredient (API) and Excipient Suppliers.
- Five years’ work experience within Regulatory Affairs after university exam is required.
- Experience from working with medical device and pharmaceutical combination products
- Experience from working with material of animal origin is an advantage.
- Fluent skills in both spoken and written English is required.

Important commitments:

- Provide Regulatory Affairs quality system support to the organization (eg. supplier change notifications, change control, reports, etc.)
- Preparing and writing global submissions and supporting documentation in collaboration with our customers.
- Review of documents prepared in collaboration with customers and suppliers
- Identifying and continuously monitoring the global requirements for drug/device and device/biologic Combination Products.
- Coordination of internal improvement initiatives within the field.

In addition, we expect you to have an interest in personal development within the field and there will be possibilities for you to attend external courses and conferences.

Interested in the position? For questions and more information please contact Sr. Recruitment Specialist Agneta A. Almquist, PhD at Rekryteringsspecialisten Life Science, Nordic.

Mobile: +46 708-28 28 89