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Senior Regulatory Affairs Specialist

  • Job reference: 922080
  • Location: Blackpool, Lancashire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 10/10/2018

OrionGroup are looking for a Senior Regulatory Affairs Specialist for our multinational medical devices client based in Lancashire are on an initial 12-month contract

Main Responsibilities of the role

  • Effectively manage regulatory activities and provide regulatory advice to support business objectives.
  • Support and coordinate regulatory approval for new products and changes to existing products byensuring that dossiers are created where appropriate in line with local country requirements (incl. CEmark and US)
  • Develop and implement regulatory strategies and plans, with support as necessary:
  • to ensure regulatory projects are standardized to obtain earliest possible registration approval,
  • to allow clear visibility to risk and early identification of regulatory challenges,
  • to enable the development and commercialization of new products and support to other business unit projects
  • Establish and maintain good relationships with, and represent the Regulatory Department to worldwide regulatory colleagues at companies, distributors and external regulatory bodies
  • Liaise with internal departments and worldwide company colleagues to provide regulatory direction, input, support and advice
  • Establish and maintain processes for maintenance of registrations.
  • Be aware of progress and developments of worldwide regulatory requirements and address changes as appropriate
  • Provide regulatory input for post market surveillance and vigilance activities, audits, non-conformance disposition, corrective and preventative actions, post market product changes and product literature approval.

Ideal Background and skillset of the successful candidate

  • 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • Strong knowledge of
  • ISO 13485 and ISO 9001, QSR
  • Understanding of MDR/MDD requirements
  • MEDDEV guidance documents applicable to Medical Devices products and processes
  • Reasonable knowledge of
  • FDA requirements
  • registration requirements in further global markets would be an asset
  • Strong understanding of Risk Management process, label and labeling, change management is desired
  • International experience preferred
  • Proven exceptional written and oral communication skills
  • Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred.
  • Strong knowledge and skills in MS Office
  • Familiarity with Technical Documentation structure according to STED required
  • Strong interpersonal and diplomatic skills
  • Team work oriented, within a multi-functional and multi-national team
  • Customer / service orientation
  • High analytical, planning and organizational skills; able to set priorities



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.