Quality Assurance and Regulatory Affairs ManagerMedical Devices Essex PermanentAttractive remuneration packageRole requirements:Maintaining, championing and developing the compliance and effectiveness of the Business Quality Management System...
The Regulatory Affairs Manager is responsible for the lifecycle management of key EU Post approval activities, ensuring smooth integration of new products following launch with all associated post approval activities.
This would include Strategy planning, Communicating with internal Stakeholders and Health Authorities, ensuring Regulatory submissions are to the highest quality, compliant and in line with the business timelines.
- Maintain up to date knowledge of relevant regulations and guidelines, and propose strategies for effective implementation, knowledge sharing and advice to project teams
- Implement agreed regulatory strategies to plan, anticipate and resolve roadblocks, escalate issues through effective communication
- Proactively communicate with relevant internal stakeholders and external contacts, e.g. partners, and induce a trustful working relationship to ensure regulatory requirements for submissions are met and approvals expedited
- Ensure preparation, submission, approval and maintenance of high quality documentation, following current best practice standards
- Provide expert advice and support to brand teams and other areas of the business
- Provide input into the budgeting process e.g. relating to regulatory fees and CRO support required for prospective regulatory submissions
- Manage own workload to ensure agreed regulatory timeframes are met, and propose solutions to own manager if resource constraints
- Manage, coach and mentor peers and direct reports, if applicable, to deliver business objectives, ensuring their continued personal development
- Maintain data and documentation in compliance within regulatory systems and procedures
Experience / Qualifications
- Life Sciences Qualified.
- Extensive EU Regulatory Affairs experience within Life Cycle management via MRP, DCP, and CP
- Considerable regulatory experience with AU and NZ MAA and LCM regulatory requirements and processes
- Ability to analyse and interpret complex issues, and develop and communicate strategies and plans to resolve
- Seeks and accepts responsibility to enhance overall business performance
- Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
- Able to contribute to budget preparation and review
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.