Regulatory Affairs Supervisor
Location: Littleport, Cambridgeshire - CB6 1SESalary: £45k + BenefitsContract: Full time, PermanentHours: 37.5 pw
Benefits:
• 25 days holiday a year plus bank holidays, increases with length of service• Company pension scheme, minimum 4% contribution• Private healthcare after successful completion of the probationary period• Death in service - 4x salary• Enhanced Sick pay scheme• Free fruit each day• On-site Parking• Company events
Overall Job Purpose:
To manage the Regulatory Affairs (RA) function in Omega Diagnostics to ensure it performs to a level that allows the organisation to meet all its regulatory responsibilities.HR Coordinator - Job Purpose:
Regulatory Affairs Supervisor - Main Areas of Responsibility:
• Lead by example and demonstrate consistent, good HR practice and people management.• Motivate the team to achieve potential through PDR's, regular 1:1's, and training or development. Manage day-to-dayRegulatory Affairs activities providing guidance and support to the Omega Diagnostics Regulatory Affairs team.• Planning, coordination, and management of regulatory documentation activities.• Review and compilation of Medical Device Files (such as Technical Files, DHF) for Omega Diagnostics products toensure adequate compliance with regulations.• Preparation of documentation in support of regulatory function, i.e., post-market surveillance reports, riskmanagement plans/reports, and others, as required.• Preparation of documentation in support of Omega Diagnostics regulatory submissions to comply with regulatoryauthorities for registrations of products worldwide to gain marketing authorization.• Notification to regulatory authorities, where applicable, of significant product changes to retain marketing authorization.• To liaise with partners and regulatory authorities to support regulatory submissions and vigilance activities.• Review and approve product labelling, including instructions for use, container labels, packaging artwork, promotionaland training material for Omega Diagnostics products, as required.• Review and approval of product development verification protocols and reports.• Implementation and maintenance of a UDI system.• Maintenance of Regulatory procedures to ensure continued compliance.• Responsible for post-market surveillance activities.• To ensure regulatory processes are followed and within required timeframes.• Supporting internal and external audits to represent Regulatory Affairs positions and processes.• Assess changes in regulations and determine their impact.• Lead, mentor, and train team members as required.• To be involved in ODL's areas of cGMP and continual improvement in all aspects of the QMS.
Regulatory Affairs Supervisor - Knowledge, Qualifications & Skills:
Essential:
• Knowledge of regulatory submission requirements for medical devices or IVDs in EU and MDSAP Countries (Canada, Brazil, Australia, USA)• 5 year's experience in a regulatory position or professional qualification in Regulatory Affairs.
Desired:
• Supervisory experience• Familiarity with IVD regulations• Broader global regulatory requirements
Our core values:
• Customer Focus: customer satisfaction is not a department, everyone is responsible; listening to customers drives improvement• Accountability: ask "what more can I do"; takes ownership• Collaboration: actively support your colleagues; be clear in communication; celebrate success and have fun together• Respect: treat others as we would wish to be treated; respect the environment we work and live in• Honesty: aspire to be open and transparent; take pride in building trust between ourselves and others
Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks, please assume that your application has been unsuccessful.
If you feel you have the necessary skills and experience to be successful in this role, click on "APPLY" today, forwarding an up-to-date copy of your CV together with a covering letter explaining how you meet the essential criteria.
No agencies please.
