Principle Regulatory Affairs Specialist (Medical Devices)

England Permanent
  • Global Medical Device Business
  • Excellent career progression opportunities

About Our Client

My client is a global Medical Device manufacturer that provides medical devices that are designed to improve the health and quality of people's lives around the globe.

Job Description

  • Apply technical solutions to problem solving
  • Apply technical solutions to quality improvement projects
  • Use technical writing skills to clearly describe technical information
  • Working with Quality, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues
  • Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
  • Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks
  • Analyze customer complaints, identify trends and execute corrective actions
  • Review and assess of change control activities for potential impact on current regulatory filings.
  • Maintenance of Regulatory procedures to ensure continued compliance.
  • Ensure continual Quality System compliance by adherence to established and evolving internal requirements.
  • Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices.
  • Support Regulatory inspections at the site as directed.
  • Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
  • Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

The Successful Applicant

  • 4/5 years experience in R&D, QA/RA, Validations - essential
  • 4/5 years experience in Risk, Clinical and Biocompatibility - an advantage
  • Excellent technical writing experience within a medical device environment - essential
  • Attention to detail and accuracy - essential
  • Fluent English, both written and oral - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
  • Excellent analytical ability
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management

What's on Offer

Competitive salary and company benefits

Remote working with adhoc travel to site

Excellent opportunity for career progression and be apart of a rapidly growing team

Kelly Percival
Quote job ref
Phone number
+44 1727 730 143

Job summary

Life Sciences
Regulatory Affairs
Healthcare / Pharmaceutical
Contract type
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference