Senior Regulatory Affairs Associate

4 months ago

Leeds, United Kingdom Surgical Innovations Full time

**About us**

For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for mínimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field.

Our success is our people and we currently employ over 100 staff from our head office in Leeds. We place great value on our mutually respective relationships, a workplace which is collaborative and dynamic, and a culture which is inclusive and purposeful. The result; a platform for individual development, growth, and prosperity.

As we seek to identify, nurture, and retain talent, we offer competitive benefits packages, continuous training and development opportunities to ensure those joining us on our journey, grow too

**About the Position**

The role of Senior Regulatory Affairs Associate is focused on the regulatory requirements of the business in line with timelines set by relevant authorised bodies. In addition, participating in the day to day regulatory requirements of the business which will involve working on departmental priorities to meet the demands of the business. The role may require participation in areas of quality to ensure efficiency of business activities, continuous improvement, and compliance.

**Responsibilities**

On a day to day basis you will:

- Oversee and assist with global product registrations in accordance with country-specific requirements and internal systems
- Write and prepare of technical documentation to meet regulatory submission requirements e.g. CE submissions and US FDA 510k submissions.
- Update and maintain technical files.
- Proactively seek updated regulatory intelligence.
- Update quality management system as required, in accordance with regulatory intelligence.
- Determine regulatory pathways for product registration in various global countries.
- Update relevant global, regional and local databases in the product registration process, as appropriate.
- Organising and maintaining reporting schedules for regulatory actions i.e. licence renewals.
- Perform medical device regulatory compliance gap analyses and implementation.
- Lead medical device labelling compliance.
- Regulatory point of contact for international distributors, providing support for enquiries and requests.
- Perform distributor evaluation and approval.
- Participation in activities required for MDR transition (i.e. QMS updates, technical file updates)
- Provide regulatory input on project teams for projects including but not limited to new product development, continuous improvement, regulatory compliance.
- General administration such as filing and maintaining electronic and physical regulatory records

**Requirements**:

- Essential_
- Relevant experience in the medical device industry
- Understanding of EU medical device regulations (MDR) and MDSAP
- Organised & self-motivated with the ability to meet deadlines
- Excellent written & verbal communication skills with high level of IT knowledge
- Strong understanding of multi-national regulatory strategy
- Customer oriented with the ability to develop positive relationships

Desirable
- Degree educated or equivalent, preferably in a science or engineering field
- Knowledge of the requirements of ISO 13485:2016
- Project management skills

**What we offer**

This role offers a competitive salary of £40,000 to £45,000 and a range of benefits including a 9-day working fortnight (every second Friday off), pension, bonus scheme, life assurance, income protection, health cash plan, perkbox, and free parking.

**Job Types**: Full-time, Permanent

Pay: £40,000.00-£45,000.00 per year

**Benefits**:

- Company pension
- Cycle to work scheme
- Flexitime
- Free flu jabs
- Free parking
- Health & wellbeing programme
- Life insurance
- On-site parking
- Sick pay

Supplemental pay types:

- Bonus scheme

Work authorisation:

- United Kingdom (required)

Work Location: In person

Reference ID: SI_QA_02

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