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Regulatory Affairs Specialist - Junior

  • Job reference: 924194
  • Location: Wokingham, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 05/03/2019

Orion Group are recruiting for a Regulatory Affairs Specialist - Junior on behalf of our Multinational Medical Device Client on an initial 8 month contract which is based in the Berkshire Area.

Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area.

Responsibilities:

  • Ensuring that the company's products comply with relevant legislation and standards
  • Keeping abreast of international legislation, guidelines and customer practices
  • Keeping up to date with a company's product range
  • Working knowledge of medical devices regulatory documentation
  • Developing and writing clear strategies and arguments and explanations for new product licenses, modifications and license renewals
  • Preparing submissions of license variations and renewals
  • Setting and communicating timelines for license variations and renewal approvals
  • Advising scientists and manufacturers on regulatory requirements
  • Resolving complex issues as they arise
  • Maintaining quality systems undertaking and managing regulatory inspections
  • Reviewing company practices and providing advice on changes to systems. Liaising with, and making presentations to regulatory authorities
  • Submitting license applications to authorities to strict deadlines

Qualifications

Successful graduation in a Life Science degree or equivalent

  • Proven expertise of medical device Regulatory Affairs on a European Basis
  • Proven ability of interpreting legislation and impact to meet commercial needs
  • Proven capability of successful working relationships with regulatory bodies
  • Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions
  • Excellent communication and interpersonal skills, ability to influence and motivate
  • Proven success at managing and driving a team to meet strategic goals and KPIs

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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