A Regulatory Affairs & Quality Systems Supervisor is required by CareerWise Recruitment for our Galway based client. The QS/RA Supervisor will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation. Key role of this position is to support company goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company's range of Medical Devices. Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS and other International Regulations. Please contact Tom Devaney for more information.
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.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)