Danaher Corporation Senior Regulatory Affairs Specialist in London, United Kingdom
Senior Regulatory Affairs Specialist
The role is remote working and can be based anywhere in the UK or Europe
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna /
Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world.
Prepare and manage product registrations of CE-IVD products under IVD-D and IVD-R. Represents RA in New Product Development Core Teams, sustaining, supporting and representing Regulatory Affairs on the product life-cycle management teams as needed. Reviews materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keep abreast of changes of new or updated regulatory policies and issued guidance. Responsible for regulatory project timelines and management of regulatory submissions.
Essential Job Responsibilities:
Lead regulatory activities including planning and reviewing of regulatory submissions.
Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.
Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
Interact with global regulatory leaders and peers to expedite approvals and continuously improve processes
Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
Bachelor’s degree in field with 5+ years of related work experience OR Master’s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience.
Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
A minimum of 5-7 years of experience in regulatory/Quality or related departments within an IVD or Medical Device industry
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid