Accessibility Links

Regulatory Affairs Assistant

  • Job reference: 920536
  • Location: Wokingham, Berkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 09/07/2018

OrionGroup is looking for a Regulatory Affairs Assistant for our multinational lifesciences client based in the Berkshire area on an initial 6-month contract.

Main Responsibilities of the role
* Impact assessment of regulatory changes on products, business/licenses and patients/HCP
* Works with RA team members (Franchise and Regions) commercial partners to oversee the regulatory aspects.
* Deployment of local regulatory requirements
* Monitoring local Regulatory Environment and feed-back to relevant stakeholders
* Coordination of the deployment of the companies standard requirements as e.g. copy review
* Ensures organization compliance with all applicable regulations and the companies policies
* Performs Impact assessments of regulatory changes on products, business/licenses and patients/HCP
* Responds to product information requests
* Review and approve product packaging and instructions for use in compliance with local regulatory requirements
* Reviews Copy Review Material
* Administration support of the local copy review
* Responsibility for monitoring and tracking each submission, and leading the fortnightly review of jobs, provision of metrics
* Performs environmental reporting
* Reporting sales of products to meet environmental obligations in the UK and Ireland
* Requesting relevant registration documentation from parent franchise
* Administration support of Regulatory Affairs inbox

Desired Background and skillset of the successful candidate:

  • High degree of initiative.
  • Team player, fosters the strength of a network
  • Communication and negotiation skills.
  • Open minded, listens to others
  • Customer focused
  • Fluent in English
  • Well organized, sense for detail
  • Diplomacy
  • Degree level education
  • Ideally 2 years working in a Medical Devices Company

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.