Regulatory Affairs Associate

**About AMS**
**Who are Advanced Medical Solutions?**

When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we're not joking. But we're much more than that...

With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We're highly dependent on the creativity of our employees for our future growth and success. Our motto **'Care, Fair, Dare'** summarises our culture, and defines the principles of how we operate as one team to achieve success.

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.

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Job Details*
We're currently looking to recruit an Regulatory Affairs Associate, to cover a period of Maternity Leave over 9 months. The role is supporting our Wound Care Business, and can be home-based.You’ll be responsible for preparing Post Market Surveillance plans for our world-leading range of Woundcare products, and using the data to create outlining the ways in which our products can be improved for customers.
On a day-to-day basis, you can expect to be supporting the team with the new Medical Device Regulations (MDR), and enhancing the current system ready for the new requirements. You’ll also be managing our vigilance system on a global basis, and feeding back into R&D for the design of new products.

**Key responsibilities**
**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.

**Employment Basis**
Temporary - Maternity cover

**Location Country**
United Kingdom

**Location City**
Winsford

**Applications Close Date**
28 Feb 2023

**Job Type**: Temporary