Senior Regulatory Affairs Associate contract job

2 weeks ago

Leeds, United Kingdom Surgical Innovations Ltd Full time

For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally 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. 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

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.

Write and prepare of technical documentation to meet regulatory submission requirements e.g. 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.
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

Relevant experience in the medical device industry
Understanding of EU medical device regulations (MDR) and MDSAP
Strong understanding of multi-national regulatory strategy
Degree educated or equivalent, preferably in a science or engineering field
Project management skills

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.

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