Regulatory Compliance Specialist - Medical / MEDDEV
Role: Regulatory Compliance Specialist
Type: Full Time Permanent
Location: Winnersh, Reading
Benefits: Work from home flexibility, excellent contributory pension scheme, free gym membership, medical life assurance and 25 days hols + more.
This role provides Regulatory support to the Customer Advocacy team. The incumbent will be responsible for supporting the integration of new product development and acquisitions into the BD infusion compliance model. They will be primarily responsible for the notification and evaluation of Incident and Field Safety Corrective Actions on new product acquisitions. In doing so, they will act as liaison with competent authorities for vigilance/FSCA/FSN matters and ensure complete, accurate and timely reporting as required by regulatory agencies. They will also act as a backup for Regulatory Compliance requirements on existing infusion platforms as required.
MAIN ROLE AND RESPONSIBILITIES
This provides a general focus for the requirements of the role but is not exhaustive.
- Support integration of new products acquisitions into Customer Advocacy process
- Determine regulatory reportability of events.
- Prepare vigilance reports and communications to Competent Authorities ensuring filing within the required timeframe.
- Coordinate the preparation and execution of FSCA/FSN for new product acquisitions
- Escalate high priority issues as well as identified business risks to the appropriate management level.
- Support and participate in audits performed by internal and external (e.g. Notified Body) representatives
- Support other infusion platforms with Regulatory Compliance tasks as required.
- Maintain awareness of new and developing trends and requirements related to the evaluation and reporting of medical device related incidents.
- Integrate BD infusion compliance model for new product development, acquisitions and third party manufacturing solutions as required by business
- Any other ad hoc duties as required by the Regulatory Compliance Manager.
- Experience in Adverse Event handling and vigilance reporting in accordance with applicable MEDDEV guidance and European/Emerging Market regulatory requirements for post market activities
- Knowledge of European Medical Device Directive and the new Medical Device Regulation
- Strong understanding of FSCA and FSN reporting in accordance with applicable MEDDEV guidance and European/Emerging Market regulatory requirements for post market activities
- Experience in healthcare industry or medical device manufacturing
- Conscientious, detail orientated approach to work
- Excellent written and verbal communication skills
- High levels of planning and organisational skills
- Professional self-starter; able to work alone and as part of a team
- Interpersonal skills with ability to influence others
- Computer literacy with Microsoft Office packages with a strong working knowledge of Excel and PowerPoint
- Ability to effectively present information to management, groups and/or customers.
- Ability to deal with sensitive information in an appropriate and confidential manner
Some travel may be required occasionally, in the UK and abroad
The successful candidate would have a strong sense of customer focus, be conscientious, detail oriented and have excellent written and verbal communications skills.
He or she will will have high levels of planning and organisation skills and be able to effectively present information to management, groups and /or customers as well as deal with sensitive information in an appropriate and confidential manner.
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This job was originally posted as www.jobsite.co.uk/job/960505335