Senior Regulatory Affairs Associate

Job Title: Senior Regulatory Affairs Associate
Contract Type: Contract
Location: Scotland, Scotland
Salary: Competitive
Start Date: 2019-09-04
Reference: BH-114180
Contact Name: Gregory Robertson
Contact Email:
Job Published: September 05, 2019 09:22

Job Description

6 or 12 month contract –Senior Regulatory Affairs Associate – Medical Device

My client, an established Medical Device company in Scotland are looking for an experienced Regulatory Affairs Professional to join them on a 6 or 12 month contractual basis. There is a possibility or part-remote/remote working depending on experience.

Senior Regulatory Affairs Associate | Key Requirements:
  • Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
  • Produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with continuous improvement programmes and/or changes required through standards.
  • Investigate, remediate and successfully conclude all regulatory issues that are product related.
  • Support the regulatory team in processing global product registrations and approvals for chosen markets
  • Support Risk Management activities
  • Understand and apply quality assurance procedures in line with ISO 13485:2016 quality management system standards, the Medical Devices Directive 93/42/EEC (as amended) and Medical Device Regulation MDR 2017/745.
  • Ensure personal compliance with internal regulatory, quality and other procedures.
  • Ensure the company is compliant to global regulatory requirements for quality systems and product registrations
Senior Regulatory Affairs Associate | Key Requirements:
  • A minimum of 5 years’ experience working within the medical device industry
  • A high level of competence with MDD regulations
  • Experience with high risk medical devices
  • Lead pre-market submissions
  • Sound understanding of ISO13485