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Senior Regulatory Affairs Specialist

  • Job reference: 922837
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 05/12/2018

Orion group are recruiting a Senior Regulatory Affairs Specialist, (Compliance & Sustaining) on behalf of our multinational medical device client based in Northern Scotland

This is a Permanent Position

Main Responsibilities:

  • Supports RA Manager, Policy & Intelligence to assess the impact of changing regulatory requirements on the ongoing compliance of product portfolio to local country regulations
  • Reviews and evaluates product, process and supplier changes on the status of regulatory licenses globally, including the sourcing and collation of assessments from regional regulatory partners
  • Prepares EU and US submissions and communicates with the Health Authority through the review process (or rationale for justifying no submission) needed to approve such change
  • Partners with cross-functional change owners and global RA partners to plan global regulatory submissions and approvals for implementation of change in accordance with local regulatory requirements
  • Co-ordinates and supports Standards Management Process including monitoring, gap assessment completion and implementation of compliant solutions to new and revised standards, as well as FDA Guidance or EU Regulations as applicable, to ensure continued compliance
    • Performs annual review of CE marking Technical files and annual US Medical Device facility registrations and device listings
    • Supports global product removal and correction activities as required.
    • Provides Regulatory Affairs support during internal and external audits
    • Maintains Regulatory processes and procedures
    • Provides guidance and support to other Regulatory staff
    • Participates in special assignments as required
    • Performs directed activities and aids in preparation of documentation supporting product liability legal actions and claims and interfaces with outside counsel as required

Required Skills:

  • A degree/equivalent in a scientific discipline
  • Knowledge and understanding of EU and US and Global Medical Device Directives and requirements
  • Working knowledge of Microsoft Windows Software :- Word, Excel, Access and Powerpoint
  • Proven medical device, diagnostic, or related industry experience.
  • Must be able to communicate effectively in writing and verbally with government agencies and internal and external customers
  • Excellent analytical capability, and independent problem-solving ability

Desired Skills:

  • Familiarity with ISO 13485 requirements
  • Technical experience gained in an R&D laboratory setting

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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