Regulatory Advisor, Medical Devices

5 months ago

Nottingham, United Kingdom Boots Full time

Summary
Job Reference:

- 219676BR
Nottingham Support Office

Permanent

**Overview**:
As Regulatory Advisor for Medical Devices you will be joining a team of experienced and best in class Regulators in delivering regulatory insights and controls to ensure the compliance of new and existing Boots Own brand products, combined with Safety and Vigilance activities to protect both our customers and our reputation.
You will report into the Regulatory Manager for Medical Devices and will take responsibility for the compliance of medical devices across several healthcare categories, supported where required. You will stay at the forefront of changing Regulation and work closely with a cross functional team to deliver and maintain a compelling and differentiated Boots brand medical devices range.

**Key responsibilities**:

- Provide regulatory guidance and support during new product development.
- Obtain and review relevant due diligence documentation from suppliers to ensure regulatory compliance for UK and EU markets.
- Work with the Project Team to prepare wording and compliant artwork for new products.
- Manage regulatory change controls to ensure on-going compliance.
- Support Vigilance activities including preparation of Post Market Surveillance Reports.
- Keep up to date with the current legislation/ guidelines and share the knowledge with the team

**What you’ll need to have**:

- Life Sciences degree or equivalent qualification/relevant experience
- At least 2 years’ experience working in a relevant regulatory environment, preferably within EU Medical Devices
- Strong technical knowledge
- Have a logical and enthusiastic approach to problem solving
- Ability to handle multiple tasks in a fast-paced and constantly changing environment with limited supervision.
- Ability to think and work independently
- Excellent verbal and written communication skills which will allow you to communicate complex technical information to wide stakeholder groups, in an effective and engaging way
- Excellent interpersonal skills, flexibility and adaptability
- Strong accuracy skills
- Ability to work well on own and as part of a team

**Hybrid Working (3 set days in the office)**

We offer our Support Office team members a 3/2 hybrid working approach, based upon empowerment, accountability, care, and trust, which includes a mix of remote and office-based working - our set office days are Tuesday, Wednesday and Thursday and WFH days are Monday and Friday.

**Why Boots**:
You'll be joining a company that is evolving and always looking to improve. We foster a working environment where consideration and inclusivity help everyone to be themselves and reach their full potential.
We’re proud to be an equal opportunity employer, passionate about embracing the diversity of our colleagues and providing a positive and inclusive working environment for all. As the heart of everything we do at Boots, it's with you, we can chang

**Our benefits**:

- Boots Retirement Savings Plan
- Enhanced maternity/paternity/adoption leave pay
- Discretionary annual bonus
- Generous employee discounts

Flexible benefits scheme including discounted gym membership, life assurance, activity passes, holiday buying and much more.

**What’s next**:

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