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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

POSITION SUMMARY:

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

MINIMUM REQUIREMENTS:

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

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