Regulatory Affairs Associate; Post-Market – Winsford, England
Full-time Tier 2 Jobs Recruiting posted 5 years ago in Sales/ Marketing Shortlist Email JobJob Detail
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Proposed Salary Attractive Remuneration
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Career Level Staff
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Experience 2 Years
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Gender Any
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Industry Business/ Management
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Qualifications Bachelor's Degree
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Email [email protected]
Job Description
What will this role involve?
- Implement and maintain the post market surveillance process and SOPs.
- Prepare Post Market Surveillance Plans, Reports, Periodic Safety Update Reports (PSURs) with input from other functions where required.
- Create schedule and ensure adherence for; PMS plans, PSURs, PMS reports, and SSCP.
- Review and analyse adverse event trending during PMS cycles
- Support complaint reduction, and product performance improvement programmes
- Support Risk Management System activities by supplying post market data to key internal stakeholders
- Monitor post market surveillance activities to support reports on the status of such activities on a periodic basis such as vigilance reporting, customer feedback, post market clinical trends and pro-active market feedback.
- Ensure appropriate governance of complaint coding schemes.
- Upload PMS data to country specific electronic systems where required
- Responsible for preparation and approval of Incident Reporting and FSCA/Recall reporting to meet regulatory requirements worldwide.
- Establish, manage and maintain good relationships with Regulatory Authorities and be the point of contact in respect of Vigilance (Incident Reporting, FSCA/Recall).
- Liaise with customer and Registration Holder for Incident Reporting and FSCA/Recall activities, within the terms of existing contractual obligations.
- Act as PMS and Vigilance Subject Matter Expert for participation in audits including FDA inspections and Notified Body audits
- Collaborates and interacts with internal teams, including R&D, Sales, Marketing, Regulatory Affairs, Clinical, Quality, Engineering, etc.
What we’re looking for?
- Degree, or equivalent qualification, in a Life Science, or equivalent industry experience
- Knowledge of relevant GMP and Quality Systems standard, specifically with FDA Quality System Regulation and ISO 13485 relevant to this role
- Understanding of the European Medical Devices Regulation (MDR) relevant to this role
- Experience of working in a regulated environment
- Understanding of Risk Management within a Medical Device industry
- Ability to query and analyse data
- Demonstrated organisational skills
- Ability to work under pressure to meet process/project time frames, regulatory requirements and company requirements
- Competent IT skill in preparing files.
- The ability to influence and challenge others in a constructive way so as to deliver improvements.
- Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities.
Think you have what it takes?
If you share our passion for ensuring that patients & customers can receive high quality products that match their needs, click apply, or send us your CV to [email protected]
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
