Telephone: 086 8395533
Quality Systems /Regulatory Affairs Supervisor
Our client, a medical device company in Galway is currently looking to recruit a QS-RA Supervisor for their site.
The QS/RA Supervisor is responsible for:
Development, collation and review of data for US FDA regulatory submissions:
- 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
- Performs regulatory review of product labelling and IFU, provides PMAP review
Supervision of regulatory and quality systems personnel including:
- Document Control, Quality Systems Engineer, regulatory specialists
- Maintain Core records for all direct reports and raise issues concerning timekeeping should they occur
- Carry out a regular 1:1 meeting with reports as well as a mid-year and annual review.
- Ensure that in your absence (or absence of any of your reports) your areas of responsibility provide adequate day to day service. Ensure that other departments know of your arrangements well in advance
- Assist in complaint and CAPA investigation and root cause analysis, and performance of effectiveness activities.
- Ensure complaint activities are performed in a timely manner including reportability reviews, Health Risk Assessments and submissions as required.
- Project meeting attendance as required.
- Work efficiently using own initiative, escalating decisions to the Quality Manager as, when, and only when, necessary.
Minimum Education And Experience Requirements:
- College graduate with 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
For further information on this QS-RA Supervisor role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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