Senior Regulatory Affairs Engineer
Elekta
full-time
Posted on:
Location Type: Hybrid
Location: Crawley • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- Support the Post Market Surveillance Manager developing, implementing and maintaining appropriate and consistent systems and procedures to meet the business objectives
- As a member of the complaint unit, ensure that all product safety cases are quickly identified, assessed for patient risk and escalated appropriately to ensure proper action and /or agency notification is taken
- Ensure the reporting of adverse events to the appropriate authorities are carried out within specified timeframes
- Liaise with external regulatory bodies and internal regulatory functions within Elekta on AE reportable complaints
- Provide awareness training, as required, to ensure that everyone in the Business is aware of the importance of Complaints and the need to deal with them in a timely manner
- Monitor that complaints are closed in accordance with the defined targets and make raising non-conformances where necessary
- Any other Post Market Surveillance activities as required to support the departmental goals
Requirements
- Advanced qualification or experience in the medical device industry, preferably with global exposure
- Knowledge of Medical Device Regulatory Affairs, specifically Post Market Surveillance and Vigilance
- Experience with complaint handling requirements in the medical device industry
- Proven experience in regulatory affairs within the medical device industry, with a strong focus on post-market surveillance, vigilance, and product recalls.
- In-depth knowledge of EU and US medical device regulations, including hands-on experience with notified body audits.
Benefits
- Hybrid work option (you are required to work from the Crawley HQ at least 3 days/week)
- Up to 25 paid vacation days (plus bank holidays)
- Holiday Purchase Scheme
- Private Medical Insurance
- Attractive Employer Pension Contribution Package
- Cycle to work scheme
- Life Assurance
- Onsite subsidized restaurant, offering budget-friendly dining
- Love electric (Electric vehicle salary sacrifice scheme)
- Hybrid work option (you are required to work on location at least 3 days/week)
- 30 paid vacation days/year, additional 4 Elekta days off /year (plus bank holidays)
- Attractive defined contribution pension scheme
- Private Medical Insurance
- Lunch Benefit
- Contribution to wellness activities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Post Market SurveillanceVigilanceComplaint handlingRegulatory affairsMedical device regulationsNotified body auditsAdverse event reportingRisk assessmentNon-conformance managementProduct recalls
Soft skills
CommunicationTrainingLiaisonMonitoringProblem-solving
Certifications
Advanced qualification in medical device industry