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Reg Affairs Project Lead

  • Job reference: 930236
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 26/02/2020

Orion Group Life Sciences have an exciting opportunity for a Reg Affairs Project Lead for our Multinational Medical Devices client based in the Cork area on an initial 12-month contract.


Job Purpose

The Project Lead, Regulatory Affairs serves as a technical expert on Regulatory Affairs matters and is responsible for providing assistance in the preparation and submission of global regulatory documents with little to no supervision. This position may act as a team lead and is accountable for the success of projects. This position may be the primary contact for new product development teams. Individuals in this position frequently have significant amounts of critical organizational knowledge. Positions at this level are considered subject matter experts.


Main Responsibilities of the role

  • The Project Lead, Regulatory Affairs provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches
  • S/he leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
  • This role represents Regulatory Affairs on cross-functional project teams and guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
  • S/he defines data and information needed for regulatory approvals by partnering with other functions, plans for project regulatory deliverables, and monitors a project through completion
  • The Project Lead, regulatory affairs assists in the development of best practices for Regulatory Affairs processes
  • In this role the Project Lead, Regulatory Affairs will aid in the development of labeling specifications and approval of proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
  • The Project Lead, Regulatory Affairs will provide Regulatory Affairs support during internal and external audits

Desired Experience and Background of the successful candidate

  • A minimum of a Bachelor's degree is required, preferably in biological/life sciences or engineering discipline
  • Bachelor's degree with minimum 6 years related experience in a regulated healthcare environment or industry
  • Practical experience with the preparation and submissions for Class II and III medical devices is required
  • Experience with US FDA Regulations and European Medical Device Directives required. Experience in worldwide regulatory systems preferred
  • Outstanding written and oral communication skills are required
  • Demonstrated expertise in medical device regulatory requirements and processes is required
  • Demonstrated expertise in orthopaedics and orthopaedic device regulatory requirements is preferred
  • Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously is required
  • Must be capable of providing direction and training to junior colleagues

#medicaldevices #medical #device #13485 #multinational #product #implant #regulatoryaffairs #labelling

For more information on this role, call Daniel Ryan on +353868140295 or email Daniel.Ryan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930236


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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