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Job Details

Manager Regulatory Affairs - Medical Device, Germany

Company: Barrington James Clinical
Location:
Reference: CRBG-RADEVMAN
Closing Date: 04 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

For more information call Carlos Biggemann on +44(0)1293 776644 or email me cbiggemann@barringtonjames.com

Requirements:

Main Purpose of Job:

The Regulatory Manager EMEA is responsible for efficiently obtaining and maintaining product registrations in non-CE countries in EMEA by working closely with distributors, agents and consultants.

Key Duties & Responsibilities:

  • Participation in local, regional and/or global level in projects where regulatory input is required
  • Providing input to the Global Submission Plan with regard to regulatory strategies to obtain approval for new products or planned changes
  • Ensures that submissions as planned in the Global Submission Plan are executed on-time and in a cost-effective manner.
  • Licenses for approved products are maintained and renewed on-time.
  • Adequate and effective relationship management with Third Party License Holders, Legal Agents, Regulatory Agencies, Consultants, and internal stakeholders in order to meet the regulatory goals and timelines.
  • Is accountable for compliance of the submitted registration files with internal requirements and external regulations.
  • Supports the business in obtaining timely regulatory documentation required to import/export and/or to obtain reimbursement approval
  • Ensures that changes that require notification are identified and that submission are conducted accordingly with minimum impact on product supply or internal processes.
  • Ensures that promotional and marketing material used is compliant with internal and external requirements
  • Monitors changes in local standards, regulations, guidance documents etc. and inform the relevant stakeholders in the company in case of impact.

Essential Experience/Skills:

Education:

Minimally University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology. Degree in Engineering or equivalent technical experience

Experience:

Minimum 4-year submission experience in Regulatory Affairs in Medical Device/Pharmaceutical industry in EMEA, preferably in a multi-cultural environment.

Skills/ Knowledge/ Ability:

  • Experience with handling regulatory submissions in non-CE countries in EMEA.
  • Excellent interpersonal and communication skills
  • Able to work independently with minimal supervision
  • Meticulous and attention to details.
  • Strong technical writing skills
  • Good English communication skills across different departments and organizations

Apply for this job: Manager Regulatory Affairs - Medical Device, Germany

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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