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Senior Manager Global Regulatory Affairs

Senior Manager Global Regulatory Affairs

Job Title: Senior Manager Global Regulatory Affairs
Contract Type: Permanent
Location: Frankfurt am Main, Hessen
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: DP 160890_1517579568
Contact Name: Daniel Perkins
Contact Email: d.perkins@sciproglobal.de
Job Published: February 02, 2018 13:52

Job Description

Senior Manager Global Regulatory Affairs (m/f)

Medical Devices

Frankfurt

A top client, located in Frankfurt is currently searching for their next Senior Regulatory Affairs Manger to join their highly successful team. The company have a firm leading hold of the area of the market they are active in, and are highly successful on a global scale. They boast a highly attractive portfolio of products, with a high commitment to long-term growth and success and are working on a clear business strategy to ensure this is met.

The Role:

  • Timely and accurate preparation and submission of applications for new approvals and registration as well as answering Regulatory related queries on a global scale
  • Compiling and updating the registration dossiers, advising the involved development departments on quality, analytical methods, preclinical and clinical development to ensure data acceptance globally
  • Develop, achieve and obtain medical device approvals/registrations worldwide and associated labelling, taking into account the relevant legislation and regulatory guidelines
  • Evaluation of dossiers of third parties
  • Creation and updates of product information texts according to the Company Core Data Sheets and relevant guidelines as well as translation management
  • Receipt of approvals/ life cycle management worldwide (preparation and submissions of registration renewals, change notifications, submissions, annual reports etc.)
  • Coordination of change processes and their global implementation
  • Adequate preparation and conduct of consultations with Regulatory authorities worldwide
  • Coordinating regulatory projects, communication with third parties in regards to regulatory issues
  • Support in the development of regulatory strategies, participation in project teams, contact person in relation to regulatory requirements
  • Maintenance of regulatory database

Your Profile:

  • Successfully completed studies in a Life Science related field such as pharmacy, biology, chemistry, or an engineering background
  • 5+ years of experience in the international approval of Medical Devices
  • Excellent English proficiency both written and spoken, any other languages are a bonus
  • Good Microsoft Office skills
  • Analytical thinking
  • Well structured and precise work
  • Ability to network with internal and external partners

If you are interested in this position or have any referrals to suitable candidates, please send your application in response to this advert or directly to d.perkins@sciproglobal.de