The role is conducted in line with our Core Values which are: agility, empathy, long-term view, unity and integrity.
Ensuring continued compliance with all relevant regulatory requirements of both internal corporate standards and external regulations and standards issued by Competent Authorities, Notified Bodies and Certification Bodies.
Timely identification and co-ordination of regulatory changes to ensure no negative impact on the business. This includes development and review of product technical documentation such as medical device files and all related documents to demonstrate regulatory compliance to the Notified Body as well as regulatory dossiers required for submissions of registrations to the competent authorities where the company intends to market their products.
Post-Market Surveillance: ensure continued compliance to all relevant regulatory requirements regarding timely reporting of product adverse events to Competent Authorities. Co-ordination of Field Safety Corrective Actions (FSCA) both for products as legal manufacturer (M-BC) and distributor (S-BC) and communications with internal stakeholders, regional S-BCs and any requests raised by the Competent Authorities and Notified Bodies as a result of those actions.
* Shall implement and work to all applicable regulatory and quality requirements as stipulated within the Quality Manual, Quality Policy, and Quality Objectives.
* Shall implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives.
* Generate technical documentation for both Summary of Technical Documentation (STED) for CE and UKCA certification and for international product registration purposes.
* Support and supply information as required to SBCs, distributors, Competent Authorities and Notified Bodies relating to product registration/establishment registration in any market where markets its products.
* Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification, UKCA and registration activities.
* Manage Engineering Change Request/ Engineering Change Order (ECR/ECO) process including notification to S-BCs of changes which are notifiable under local regulations and co-ordination of translations for those ECR where RA acts as change co-ordinator.
* Creation, maintenance and compliance with Standard Operating Procedures (SOPs), internal policies and Global Business Rules (OGBR) related to Quality Management System and their training to the relevant individuals.
When required, provide support for assessment of Health Hazard Evaluations (HHE) and management of field safety notices and field safety corrective actions (FSN/FSCA).
University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
Minimum of 2 to 5 years post qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file and/or technical compliance activities.
Skills and Knowledge
* Good understanding of EU MDD/MDR, ISO 13485 and MDSAP requirements and ability to communicate and provide training on these technical and regulatory documents to a less specialist audience.
* Knowledge from a registration perspective of active medical devices, risk assessment, clinical experience, post-market surveillance, quality compliance.
Sound IT skills in Ms Office (Ms Word, Ms Excel, Ms Power Point)