Danaher Corporation Regulatory Affairs Specialist in Lognes, France
Regulatory Affairs Specialist
This is remote based role and be based anywhere in the UK or Europe
The Regulatory Affairs Specialist will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from all areas of company as well as for internal audits and inspections.
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for generation and maintenance of regulatory files
Responsible for generating and delivering documentation for registration of Cepheid products
Partner with global and regional marketing in the development of regulatory plans
Assesses potential impact and/or applicability to other related areas
Formulate short-term planning for individual deliverables and participate in long term planning within the organization
Prepare formal written reports/documents for distribution within work unit and regions
Provide training or presentations in multiple disciplines to cross-functional groups
Compile all 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.
Maintains a "focused urgency" as required by specific events
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree with 2+ years of related work experience OR
5+ years’ experience in a fast paced regulatory/compliance/quality team at a medical device/IVD manufacturing site OR
Equivalent combination of education and experience to perform at this level
Knowledge and skills:
Sound basis of Regulatory and /or Scientific knowledge
Demonstrates in-depth understanding of advanced technical/scientific principles that relate to Cepheid’s business
Expertise in Molecular Biology/Molecular Diagnostics is a plus
Ability to interpret subjective and complex aspects of specific regulations
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Strong oral and written communication and presentation skills
Ability to work independently and deliver on assigned tasks
Effective communicator of technical & non-technical information
Prior knowledge of different databases like SAP, Agile, Trackwise etc. is preferred
Masters oral and written English
Swedish fluency is a plus
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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