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.
The main technology is a surface coating with an API component that needs to comply with regulations within the fields of medical devices and pharmaceuticals. The company acts as a supplier of coating technology for customers with drug/device Combination Products with a device primary mode of action. Products with the technology are sold worldwide.
You will be coordinating the field of regulatory affairs. Commitments are highly variable and involve customer support in preparation 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.
The person we are looking for should:
• Have knowledge of EU and International regulations related to pharmaceuticals and/or drug/device Combination Products with a device primary mode of action
• Have knowledge and experience in the Pharmaceutical and/or Biologics industry, especially related to Chemistry, Manufacturing and Controls (CMC)
Experience, or interest, in following areas is also appreciated:
• Regulations pertaining to Material of Animal Origin
• Active Pharmaceutical Ingredient (API) and Excipient Suppliers
• Provide Regulatory Affairs quality system support to the organization (e.g. supplier change notifications, change control, reports, etc.)
• Support existing and new customers in preparation of global submissions and supporting documentation
• 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
• Update of Master Files at regulatory agencies
• Coordination of internal improvement initiatives within the field
About the team:
The quality team covers quality control, quality assurance and regulatory affairs.
The regulatory affairs team consists of our expert on chemistry and testing of our key API and our QA responsible for the API supplier. In addition, our other experts on the coating technology are available as needed.
Your commitment to responding to our customer’s requests by coordinating both internal resources and external expert consultants will be of great importance for the success of our business
• Work experience within Regulatory Affairs after university exam is required
• Experience from working with medical device and pharmaceutical combination products and experience from working with material of animal origin is appreciated
• Fluent skills in both spoken and written Swedish and English is required
• An interest in personal development within the field is expected and the possibility to attend external courses and conferences is offered
• 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
Interested in this new 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 E-mail: email@example.com