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Regulatory Affairs Assistant

  • Job reference: 922995
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/12/2018

Orion Group are recruiting for a Regulatory Affairs Assistant on behalf of our Multinational Medical Device Client on an initial 12 month contract based in the West Yorkshire Area

Main Responsibilities of the role

  • Provide full support to the Regulatory Project Leader to ensure that all aspects of the registration programme are conducted in accordance with the requirements of the company and the regulators.
  • Provide support to the US for FDA submissions.
  • Facilitate the product registration activities in Europe by compiling appropriate dossiers, submissions and responses to regulatory bodies.
  • Maintain processes for submissions, interim notifications and periodic re-submissions.
  • Maintain information on regulatory requirements and the status of product registrations.
  • Liaise with product development groups, marketing and sales to co-ordinate timely approvals.
  • Provide support and advice to worldwide company colleagues, particularly product development, marketing and sales, concerning international regulatory requirements in Europe.
  • Establish relationships with country personnel, regulatory bodies and appropriate company personnel to expedite the product registration process.

Desired Background and Skillset of the successful candidate

  • Degree or equivalent preferred ( Or relevant experience)
  • Forward planning, organisational and time management skills
  • Ability to use own initiative, speedily and efficiently handle enquiries and requests
  • Work to tight deadlines and remain calm in stressful situations
  • Good knowledge of MS Office products, such as Excel, Outlook and Word essential

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.