We are currently looking to identify an experienced Regulatory affairs professional who has a proven experience of working in the medical device sector. In this role you will take a key lead in managing and shaping regulatory process, working with multiple stakeholders across a variety of markets and develop towards full people management.
You will be joining a multi award winning, market leading global business who hold an outstanding reputation across a variety of medical device product specialities. In this role you will focus on a specific product range and join an established team to help continue to deliver success.
If you have regulatory experience of 4 years plus in the medical device sector and feel this role could appeal, then please apply to the role and we can establish initial discussions.
This role will primarily focus on 'post market' regulatory affairs and you will mainly focus on established products in this business portfolio. You will lead process, look to identify where the process can evolve and deliver a multi stakeholder offering that helps deliver continued success across a variety of established International markets.
This position would be ideal for someone who is established in regulatory affairs but is looking to develop towards people management.
Focussing on UK, Belgium, Netherlands and Nordics
* Executes PMS activities in line with defined procedures and processes
* Collects, organises and maintains files on local, regional, and global RAQA intelligence
* Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
* Identifies opportunities for continuous improvement and supports those activities across RAQA
* Provides support to EMEA / Country RAQA teams as appropriate
* Act as RAQA Leader, reporting performance, risks and issues to local leadership teams
* Acts as a subject matter expert to the local business
* Lead teams to support regulatory processes for market access of products
* Lead the development and deployment of new systems and procedures locally
* Plans, conducts, and supervises for Third Party, Competent Authority or Notified Body audits within the local organization
* Supports continuous improvement activities across PMS activities within the local office
* Defines targets, KPIs, performance objectives for RAQA within the local office
* Maintains a high level of team engagement and collaboration across the RAQA team in the local office
* Supports integration of new acquisitions, ensuring RAQA systems integration within the local office
* Liaison with the local business in manufacturing and Design Divisions to ensure adequate support for the local RAQA and commercial organizations
Package and Benefits
* £40 -£55k Basic Salary
* Annual bonus
* Medical, Dental
* Representing one of the best brands in the industry
Key Skills, Qualifications and Client Requirements
* 4 Years in Medical Device Regulatory Affairs
* Ideal supervisory experience of a small team 1-3 years
* Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, EU Medical Device Regulations, Quality System and Post Market Surveillance requirements
* Demonstrate technical knowledge of medical device regulatory and quality requirements
* Demonstrated ability to lead and develop employees and building effective teams
* Coordinate, support, and lead technical and scientific PMS activities
* Undertaking assignments that are broad in nature, requiring originality and ingenuity
* Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organisation, Design Divisions and third-party distributors
* Leads meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support
* Communicates information and advises on PMS requirements to other departments and business units
* Engages in communication with regulators and other key stakeholders on routine and complex matters with minimal supervision
* Preparation of PMS metrics for reporting purposes
What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at firstname.lastname@example.org or call our Medical Devices team on 01423 813456.
Please attach a copy of your most up to date CV to any emails sent for ease.
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