Telephone: 086 8395533
Our client, a medical device company in Galway are currently looking to recruit a Senior RA Specialist for their site.
The Senior RA Specialist 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.
Essential Job Duties and Responsibilities
Employees are expected to support the quality concepts inherent in the business philosophies including a variety of job related tasks which may not be specific to this position profile.
The Senior RA Specialist is responsible for:
- 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
- Performs regulatory review of product labelling and IFU, provides PMAP review
- Supervision of regulatory personnel including:
- 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 CAPA investigation and root cause analysis, and performance of effectiveness activities.
- Project meeting attendance as required.
- Work efficiently using own initiative, escalating decisions to the Quality Manager as, when, and only when, necessary.
- Be an active member of the team and work with all employees to develop a world class lean manufacturing system
Skills and Knowledge:
- Ability to communicate and work with people inside and outside the department.
- Ability to supervise
- Ability to co-ordinate, plan and organise
- Excellent attention to detail and organisation skills.
- Ability to work to deadlines and on own initiative.
- Excellent verbal and written communication skills.
- Working knowledge of Excel and Word.
- Experience with USA regulatory requirements would be advantageous.
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
Physical & Mental Demands:
- Work effectively with close tolerances.
- Ability to co-ordinate, plan and organise based on priorities.
For further information on this RA Specialist in Galway please contact Bimi on 086 8395533 / firstname.lastname@example.org
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