Regulatory Affairs Supervisor
|Title||:||Regulatory Affairs Supervisor|
|Sector||:||Engineering & Technical
Scientific & Laboratory
Executive / Management
Role of this position
- Development, collation and review of data for US FDA regulatory submissions: - PMAs & 510(k) registration
- Development, collation and review of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintains currency of CE Technical Files aligned with device and process changes.
- Key member of the R&D and NPI teams, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements.
- Develop regulatory strategies to support NPI and R&D projects
- Interpret new or revised medical device regulations and standards, develop internal procedures to ensure continuous compliance with all regulatory requirements
- Ensure all customer regulatory requests and addressed in an efficient and effective manner
- Leading the preparation and direct all activities for: - FDA inspections, ISO 13485 surveillance audits, Corporate audits, Customer audits, and follow through on close out of any subsequent actions assigned.
- Lead the Risk Management team, maintains Risk Management Files in line with real time PMS data, device and process changes. Lead Clinical Evaluation activities
- Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicable
- Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CFS updates, and vigilance and compliance issues
- Act as facility lead for all post market surveillance activities including field safety corrective action
- Level 8 Engineering or Science Degree or equivalent experience.
- Qualified Systems Lead Auditor for ISO 13485 and MDD compliance.
- Minimum of 3 years experience in a Medical device regulatory affairs role.
- Competent in preparing written communication and correspondence.
- Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical and legal professionals.
- Comprehension of Engineering principles adequate to allow participation in New Products Development and field complaint issues.
- 3 -5 years experience in a Regulatory Affairs role in the Pharmaceutical, Healthcare or Medical Device sector essential, preferably in an FDA regulated environment.
- Full & comprehensive job Specification available on request
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.