Regulatory Affairs Associate

We are recruiting for a Regulatory Affairs Associate for a permanent position in Romsey for an industry leading firm that boasts 'Investor In People Gold' status.

This is a fantastic opportunity if you ae looking for a role where you can benefit from excellent training, genuine progression and job satisfaction.

If you have experience of regulatory affairs, quality management systems and engineering then please read on.

Regulatory Affairs Associate Benefits:

• £40,000 pa.
• Working days Monday to Friday, working from home and 1 day support on site per week (Romsey).
• Life assurance scheme.
• Pension scheme.
• 24 days holiday plus bank holidays.
• Gym membership.
• Career progression opportunities.

Regulatory Affairs Associate Responsibilities:

• Support RA Director for regulatory documentation including updating technical files, reports and procedures.
• Compile vigilance PMS and PSUR reports.
• Documentational support for world-wide regulatory submissions.
• Assist with Competent Authority registrations including the MHRA and ECREP.
• Liaising with all department to obtain required documentation for technical file and registration updates.
• Create Declarations of Conformity.
• Review and manage standards database and advise / implement changes to the technical files as required.
• Support Management of Patents and Trademarks.
• Create and implement compliant Regulatory procedures.
• Demonstrate an awareness of compliance and marking, ISO QMS, ISO risk analysis, patents and trademarks.
• Support with quality management systems and engineering disciplines.
• General administration duties and reporting.

Regulatory Affairs Experience:

• UK MDR 2022 UKCA compliance and marking
• EU MDD9342eec CE compliance and marking
• UKCA compliance and marking.
• EU MDR 2017/747 CE compliance and marking
• EC 60601 family compliance ETL/UL marking
• ISO 13485 QMS
• ISO14971 Risk analysis.
• Patents and Trademarks.

For immediate consideration please send your CV to Kayleigh at Vibe Recruit today!

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.