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Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    Utrecht

  • Sector:

    Regulatory Affairs

  • Job type:

    Contract

  • Salary:

    Market related

  • Contact:

    Crystal Locke

  • Contact email:

    Crystal.Locke@catalystcareers.com

  • Contact phone:

    02035899300

  • Job ref:

    LM48020

  • Published:

    3 months ago

  • Expiry date:

    2019-12-30

Vacancy Details:

Title: RA Manager 

Location: Utrecht, Netherlands

Rate: Competitive

12-month contract

Are you looking to start the New Year with a new contract role? My client, a leading life sciences company based in the heart of the Netherlands, are looking to recruit an experienced RA Manager to support the day-to-day activities of the RA department. This will be a varied and prosperous position, ideal for someone looking to take the next step in their career.

Responsibilities:

  • Provides clear, constructive regulatory advice and guidance to global project and regulatory teams.
  • Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
  • Maintains Design Dossiers and Technical Files ensuring contents are current and accurate.
  • Performs peer review of complex regulatory documents.
  • Independently and without supervision, prepares complex regulatory documents for product approval in EAME.
  • Establishes strong and effective relationships with global regulatory teams thereby ensuring RA activities are in line with global and regional business priorities.
  • Has regulatory expertise and knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.

Requirements:

  • A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs.
  • Medical Device experience, including a successful track record in the registration and maintenance of products within Europe.
  • Knowledge of relevant Quality Standards. Direct interaction with competent authorities and Notified Bodies.
  • Excellent organisational/ planning and negotiation skills
  • Excellent communication skills, both written and verbal (in English).
  • Good interpersonal skills and the ability to influence others without formal authority.
  • Ability to work effectively and collaboratively across the global organisation and cross-functionally

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to crystal.locke@catalystcareers.com or call 0203 589 9294 for a confidential discussion about potential opportunities.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

Catalyst Life Sciences:

Catalyst Life Sciences are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical Information
  • Medical Writers
  • Medical Affairs
  • Compliance
  • Audit
  • Validation
  • Production
  • Manufacturing
  • Clinical Trials
  • Clinical Research
  • Project Management
  • Finance

My LinkedIn Profile:

https://www.linkedin.com/in/crystal-locke/

I personally specialise in recruiting QA and RA professionals for roles globally so please do get in touch should you be considering new roles or looking to fill ones at your current company!