Regulatory Affairs Officer
Purpose Of The Role
Due to growth we are now recruiting for a Regulatory Affairs Officer to work within our MedTech division.
As a regulatory affairs officer you will be the crucial link between Clarity Medtech, its products, customers and regulatory bodies.
You will have direct accountability for Clarity MedTechs regulatory requirements within the UK and liaise with our European Regulatory Support functions
You will combine your knowledge of regulatory, quality and business issues to ensure Medical Device products, which are distributed by Clarity Global Group, meet the required legislation.
Clarity Global Group Ltd is a leading Pharma & Health Sales and Distribution company. We work with a number of manufacturers providing strategic sales advice, storage, distribution and supplying to full & short-line wholesalers, pharmacies, GP surgeries and hospitals.
Founded since 1999 we have had huge success over the years, winning numerous awards and most recently in 2020 being recognised in “Pharma Fast 50” as one of the fastest growing businesses. With total group sales exceeding €100m in 2019.
Role and Responsibilities
- Act as the UK Medical Device Responsible Person on behalf of Clarity Medtech and its manufacturers
- Be the point of contact for Clarity MedTech Customer Regulatory and Quality queries
- Responsible for UK product complaint handling, Competent Authority notification and liaison with manufacturer
- Responsible for complaint reporting and resolution within national competent authority timescales and deadlines.
- Work closely with Clarity and Manufacturer Technical resource to provide findings and corrective actions in the instance of Medical Device Adverse Incidents and/or malfunctions
- Responsible for complaint handling oversight and liaison with EMEA Regulatory support functions
- Ensure that a company's products comply with the regulations and statutes of the regions where they want to distribute them
- Oversee and audit internal company regulatory compliance
- Keep up to date with national and international legislation, guidelines and customer practices
- Liaise with product manufacturers to ensure products meet submission requirements and deadlines for conformity, licence variations and renewals
- Work with specialist computer software and resources (EQMS/ERP)
- Liaise with technical and logistics teams on required sample assets
- Manage MedTech Quality Management system, SOPS and Management controls
- Review company practices and provide advice on changes to systems & processes
- Liaise with, regulatory authorities
- Negotiate with regulatory authorities for marketing authorisation
- Responsible for completion of ISO 13485 Application and certification
- Responsible for maintenance of ISO 13485 Quality Management System (once certified)
- MedTech Quality Assurance and working knowledge of Regulation-Advantageous
- QA/RA SOPS/workflows and ISO 9001 and/or 13485- Advantageous
- Solid commercial awareness, acting in the accordance of the strategic direction of the business
- Calm and can works under pressure to time frames and deadlines
- Good Communicator (Able to enter dialogue with Competent Authorities, Customers, Healthcare customers, Manufacturers and internal partners)
- Self-Starter and Detail Orientated
- Collaborative working with other areas of the business
- High levels of diligence & organisation
- Adaptable and comfortable with change
- Company benefits
- Company car allowance
- Career progression path
- Stylish new office
- On-site parking
If you believe this role could be a good match, do get in touch. We look forward to hearing from you.