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Senior Regulatory Affairs Program Lead

  • Job reference: 923642
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 12/03/2019

OrionGroup are recruiting a Senior Regulatory Affairs Program Lead on behalf of one of our Multinational Medical Device Companies Based in Northern Scotland on a Permanent basis.

Senior Regulatory Affairs Program Lead- New Product Development & Strategy

Responsibilities may include:

  • Collate global regulatory requirements to develop effective regulatory strategies for delivering optimal timelines for new/modified product approvals.
  • Provide independent regulatory guidance to business partners and cross functional project teams, communicate regulatory environment and product submission requirements
  • Prepare pre-market applications to US and EU regulatory agencies as required.
  • Partner with global regulatory affiliates to facilitate the preparation and submission of in-country registration dossiers for new and existing products, by understanding local regulatory requirements, and sourcing and providing required documentation to meet timelines.
  • Guide conformance with applicable regulations in product development, support of claims, labeling content, and promotional materials
  • Develop labeling specifications and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
  • Provide Regulatory Affairs support during internal and external audits
  • Plans schedules for regulatory deliverables on a project and oversees project through completion
  • Assists in the development of best practices for Regulatory Affairs processes
  • Represents Regulatory Affairs on cross-functional project and business teams as required
  • Partners with other functions to define and obtain data to assist with regulatory submissions and compliance activities

Requirements for this role include:

You will degree qualified in a scientific discipline with significant Regulatory Affairs experience within the medical device industry with knowledge of IVD or MD regulations in US and/or EU

Together with:

  • Specific knowledge of regulatory requirements for Software as accessory to MD/IVD and as Standalone MD)
  • Demonstrated expertise in new product development; and compiling and submitting EU (CE File) and/or US (510(k)) pre-market submissions
  • Ability to understand complex situations and develop strategic plans to meet business needs
  • Strong sense of intellectual curiosity and capability to self-teach
  • High attention to detail
  • Excellent written and verbal communication skills
  • Ability to think creatively in order to provide solutions
  • Ability to work collaboratively as part of a multi-tasking team
  • Assertive and focused

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.