Regulatory Affairs - Post Market Surveillance
- Recruiter
- Confidential
- Location
- Basingstoke
- Salary
- 38000.00 - 42000.00 GBP Annual + Bonus + Benefits
- Posted
- 15 Jun 2021
- Closes
- 13 Jul 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
Regulatory Affairs / Quality - Post Market Surveillance Senior Specialist
Company -
* Market Leader in Medical Device Market
* Worldwide Operations
* Rapidly growing
* Excellent career opportunities.
* Based Basingstoke 3 days per week and WFH x 2 per week
* Base salary GBP38-42k plus bonus
Main job purpose -
Responsible for the compliance of company and products to all relevant regulations and standards encompassing a range of different product types including Medical Devices and accessories. Taking responsibility for Importer & Distributor obligations under the UK MDR along with EU PMS reporting and complaints handling. Also assisting in QA documentation development & QMS maintenance and UKRP obligations.
Role -
Regulatory Affairs :
* Ensuring compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as "Economic Operators" under the UK MDR
* Covering the verification role on behalf of all affiliates acting as Distributors, using company databases, enterprise resource planning (ERP) systems and liaising with manufacturers to ensure the correct data is available
* Liasing with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas
* Ensuring general compliance with regulatory requirements & liaison with Competent Authorities as appropriate regarding FSN, FSCA and Vigilance requirements as appropriate
* Advice, as appropriate, on regulatory and associated PMS/complaint requirements
Quality Assurance :
* Writing and updating local/corporate procedures through the Corporate change request/control process
* Assisting in roll-out and instruction of affiliates, warehousing and distributors on appropriate QMS procedures and documentation regarding, but not limited to, MDR obligations
* Responsible for responses to enquiries/complaints etc from customers, distributors, other members of staff, regulatory authorities, national authorities, customs and imports, and related organisations - according to company procedures
* Site audits (internal & external) to ISO and related standards; support CAPA resolution
Provide :
* Appropriate reporting to the International QARA Director as required.
* Assistance with any other appropriate tasks deemed necessary by management
Key relationships -
* Work with manufacturers, importers, distributors, customer-facing and operational groups within the company to achieve successful outcomes with assigned projects
* Interaction with national regulatory authorities regarding product compliance
* Work with other RA/QA staff and supporting functions (e.g. document control) across the company who are based at a variety of worldwide locations
* Instruct as appropriate manufacturing facilities, suppliers, affiliates, warehousing and distributors on necessary QMS documentation
Applicant Experience -
* 3+ years' experience in a Medical Device RA or QA role
* Methodical, accurate and consistent attention to details
* Good knowledge of the EU Medical Device Regulations and UK Medical Device Regulations
* Auditing experience (potentially as certified auditor) would be of benefit
* Experience with ERP systems for product distribution would be an advantage
* Experience working with Electronic Medical devices would be an advantage
Ideal Applicant Qualifications -
* Undergraduate degree in a scientific discipline
* Trained in requirements of ISO 13485, ISO 9001, GMP
* Trained in requirements of the EU MDR and UK MDR
* Local EU/UK Competent Authority experience
To apply for this - or any of our exciting opportunities in the medical devices sales market - Apply Online
Progress Recruitment is a specialist sales only medical recruitment consultancy dedicated to offering client and applicants alike the highest levels of service. With over 8 years experience in recruitment we specialise in the following areas of work - Nurse Advisers, Clinical Specialists, Theatre Sales Specialists, Sales Executives, Business Development Managers, Team Leaders, Sales Managers, Sales Directors and all other sales focused roles within the medical sector. Our core therapy areas include Vascular, Endoscopy, Urology, Neurology, ENT, Infection Control, Anaesthesia, Blood Products, Diathermy, Infusion, Orthopaedics, Surgical Instruments and all PCT, Primary, Secondary, Theatre and Rehabilitation products
Company -
* Market Leader in Medical Device Market
* Worldwide Operations
* Rapidly growing
* Excellent career opportunities.
* Based Basingstoke 3 days per week and WFH x 2 per week
* Base salary GBP38-42k plus bonus
Main job purpose -
Responsible for the compliance of company and products to all relevant regulations and standards encompassing a range of different product types including Medical Devices and accessories. Taking responsibility for Importer & Distributor obligations under the UK MDR along with EU PMS reporting and complaints handling. Also assisting in QA documentation development & QMS maintenance and UKRP obligations.
Role -
Regulatory Affairs :
* Ensuring compliance of devices manufactured by the company and those products subcontract manufactured for the company, especially in the context of Importer & Distributor activities as "Economic Operators" under the UK MDR
* Covering the verification role on behalf of all affiliates acting as Distributors, using company databases, enterprise resource planning (ERP) systems and liaising with manufacturers to ensure the correct data is available
* Liasing with local Distributors to ensure seamless operation of the verification process along the supply chain throughout the relevant geographic areas
* Ensuring general compliance with regulatory requirements & liaison with Competent Authorities as appropriate regarding FSN, FSCA and Vigilance requirements as appropriate
* Advice, as appropriate, on regulatory and associated PMS/complaint requirements
Quality Assurance :
* Writing and updating local/corporate procedures through the Corporate change request/control process
* Assisting in roll-out and instruction of affiliates, warehousing and distributors on appropriate QMS procedures and documentation regarding, but not limited to, MDR obligations
* Responsible for responses to enquiries/complaints etc from customers, distributors, other members of staff, regulatory authorities, national authorities, customs and imports, and related organisations - according to company procedures
* Site audits (internal & external) to ISO and related standards; support CAPA resolution
Provide :
* Appropriate reporting to the International QARA Director as required.
* Assistance with any other appropriate tasks deemed necessary by management
Key relationships -
* Work with manufacturers, importers, distributors, customer-facing and operational groups within the company to achieve successful outcomes with assigned projects
* Interaction with national regulatory authorities regarding product compliance
* Work with other RA/QA staff and supporting functions (e.g. document control) across the company who are based at a variety of worldwide locations
* Instruct as appropriate manufacturing facilities, suppliers, affiliates, warehousing and distributors on necessary QMS documentation
Applicant Experience -
* 3+ years' experience in a Medical Device RA or QA role
* Methodical, accurate and consistent attention to details
* Good knowledge of the EU Medical Device Regulations and UK Medical Device Regulations
* Auditing experience (potentially as certified auditor) would be of benefit
* Experience with ERP systems for product distribution would be an advantage
* Experience working with Electronic Medical devices would be an advantage
Ideal Applicant Qualifications -
* Undergraduate degree in a scientific discipline
* Trained in requirements of ISO 13485, ISO 9001, GMP
* Trained in requirements of the EU MDR and UK MDR
* Local EU/UK Competent Authority experience
To apply for this - or any of our exciting opportunities in the medical devices sales market - Apply Online
Progress Recruitment is a specialist sales only medical recruitment consultancy dedicated to offering client and applicants alike the highest levels of service. With over 8 years experience in recruitment we specialise in the following areas of work - Nurse Advisers, Clinical Specialists, Theatre Sales Specialists, Sales Executives, Business Development Managers, Team Leaders, Sales Managers, Sales Directors and all other sales focused roles within the medical sector. Our core therapy areas include Vascular, Endoscopy, Urology, Neurology, ENT, Infection Control, Anaesthesia, Blood Products, Diathermy, Infusion, Orthopaedics, Surgical Instruments and all PCT, Primary, Secondary, Theatre and Rehabilitation products