What you need to know
Our Midlands based client requires a Senior Regulatory Specialist to join their team in a role where you will be developing regulatory strategies for an organisation that is a world leader in medical technology and whose products truly makes a difference to the lives of patients and medical professionals alike.
This is a permanent job on full time hours and is a role that requires travel between company sites.
Your new job
As a Senior Regulatory Specialist, you will have responsibility for the strategic planning necessary to identify regulatory requirements for submissions that ensures the efficient approval and registration of products. You will interpret new Medical Device regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements. Excellent communication skills via management and your peers will be paramount, both orally and electronically, along with acting as an effective Company liaison for local affiliates and regulatory authorities.
Key duties & responsibilities:
- Manage and maintain Risk Management Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device and process changes
- Ensures device compliance to International Regulatory requirements related to:
- New Product Introduction
- Design Control
- Site Engineering Projects
- Prepare regulatory submissions to FDA 510(k), LAPAC and other International agencies and participate in FDA facility inspections, Notified Body Audits & other governmental inspections
- CAPA investigations and Root Cause Analysis
- Reviews Change Request Notes, vigilance reporting and Regulatory review of product labelling
What are we looking for?
- At least 5+ years’ experience in a Regulatory Affairs role, or equivalent medical device industry role (i.e. quality, engineering, etc.) within a CE marking, FDA and ISO 13485 regulated medical device environment.
- Demonstrable knowledge of EU Medical Device Directive, 21CFR820, 803 and 807, and ISO 13485 requirements.
- Third-level qualification in an Engineering or Science discipline.
- Proven ability to work off your own initiative and demonstrate excellent planning and organisational skills when performing your duties.
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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