Regulatory Affairs Associate

**BASIC SALARY**: £27,000 - £38,000 (negotiable depending on experience or potential)

**BENEFITS**:

- Hybrid Working
- 1st Year Bonus Circa £5,000
- Base Salary Reviews
- 25 Days Annual Holiday (plus 8 Statutory)
- Pension (up to 10% Company Contribution)
- Free Share Incentive Plan (SIP)
- Life Assurance
- Bike2Work scheme
- Training
- Laptop
- Additional Employee Benefits

**LOCATION**: Windsor - _**Hybrid working**_

**COMMUTABLE LOCATIONS**: Slough, Watford, Reading, Luton, Oxford, Woking, Leatherhead, Surrey, Berkshire, Guildford,

**JOB DESCRIPTION**: Regulatory Affairs Graduate, Regulatory Affairs Associate, Junior / Graduate Quality Manager - Healthcare, Medical Devices, Pharma, Pharmaceuticals, Healthcare, Life Sciences

As our Regulatory Affairs Associate, your primary job function will include preparing & maintaining registration packages, in line with global international regulatory requirements & guidelines. You will provide support to distributors & authorised representatives& new product registration, including the completion of necessary documents.

**KEY RESPONSIBILITIES**: Regulatory Affairs Graduate, Regulatory Affairs Associate, Junior / Graduate Quality Manager - Healthcare, Medical Devices, Pharma, Pharmaceuticals, Healthcare, Life Sciences

This is a pivotal role working closely with our Regulatory Affairs Team.

Your duties & responsibilities will include:

- Accountability for new regulatory submissions and renewal.
- Providing regulatory support across our company and to external customers.
- Overseeing complaint analysis and reporting complaint trends.
- Responsibility for post-market surveillance & the maintenance of clinical evaluations.
- Maintaining current knowledge of relevant regulations and providing input into management review meetings.
- Reviewing and approving processes, product changes, and labelling changes, to identify regulatory impacts.
- Leading & executing transition of MDD Technical Files to MDR Technical Files.
- Creation & maintenance of Essential Requirement Checklists, Technical Files, and Declaration of Conformity for CE Marking.
- Participation in External Audits performed by external Authorities, such as Notified Body Audits.
- Working closely with our Quality Team & involvement in managing certain parts of our QMS.

**PERSON SPECIFICATION**: Regulatory Affairs Graduate, Regulatory Affairs Associate, Junior / Graduate Quality Manager - Healthcare, Medical Devices, Pharma, Pharmaceuticals, Healthcare, Life Sciences

You will have the following characteristics and experiences:

- Experience with & understanding of Medical Device Directive 93/42/EEC and Medical Device Regulation (EU) MDR 2017/745.
- Sound knowledge of CE marking of Medical Devices as per requirements set out in Medical Devices Directive 93/42/EEC and Medical Device Regulation (EU) MDR 2017/745.
- Experience & knowledge of Medical Device Symbols and Labelling requirements BS EN ISO 15223.
- Liaising with Notified Body and arranging Technical Files Audits.
- Hosting internal audits, liaising with Notified Body &arranging the audits of technical files.
- Familiarity with ISO 13485 & GMP requirements.
- Experience with risk management techniques to ISO 14971.

**OUR COMPANY**:

- We have a long-established culture of designing & manufacturing exceptionally high-quality, innovative diagnostic instruments, within the medical and health care space.
- Our customer-led NPD is constantly driving forward, creating new innovations.
- Our Group includes manufacturing, and sales & marketing operations for servicing customers spanning several continents.
- We are proud of our excellent history of investment in innovations and new markets, while continuing
- our ambitious global growth strategy.
- A hardworking yet fun and enjoyable working environment

It is highly likely you will have worked in any of the following roles and/or markets, and worked with the following products and/or services:Healthcare, Medical Devices, Pharma, Pharmaceuticals, Life Sciences, Regulatory Affairs Graduate, Regulatory AffairsAssociate, Junior/Graduate Quality Manager

**REF**: JK16916, Wallace Hind Selection