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Surgical Innovations Ltd
Leeds
Job Description About us 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
Job Source: Surgical Innovations LtdSilven Recruitment Ltd
Leeds
Senior Regulatory Affairs Associate (Interim - 1 Year) - Remote Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks. Are you a detail-oriented Senior Regulatory Affairs Associate with a comprehensive understanding of regulations surrounding supplements and nutrition claims? This
Job Source: Silven Recruitment LtdX4 Life Sciences
West yorkshire, England, United Kingdom
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, su
Job Source: X4 Life SciencesProclinical Staffing
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Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of com
Job Source: Proclinical StaffingQBE Management Services (UK) Limited
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Primary Details Time Type: Full time Worker Type: Employee At QBE, we don’t just provide insurance – we make a positive difference in people’s lives. We’re committed to helping people and businesses protect themselves from risk, so they can focus on what they do best. We do this by being the most consistent and innovative risk partner for our cus
Job Source: QBE Management Services (UK) LimitedTemplarfox Consultancy Ltd
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Regulatory Compliance Associate I am recruiting on a permanent basis in the Yorkshire region for a Regulatory Compliance Associate to work within a healthcare business. Responding to market opportunity and business requirements within online and regulated sectors. You will be responsible for: o Responsible for delivery of projects within regulato
Job Source: Templarfox Consultancy LtdBrightwork Ltd
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BaxMed – Quality Management Systems Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment
Job Source: Brightwork LtdX4 Group
United Kingdom
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, supp
Job Source: X4 GroupLeeds, England, United Kingdom
About us
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. 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.
If this sounds interesting and the right challenge for you, we look forward to receiving your application!
Senior Regulatory Affairs Associate jobs in Leeds, England, United Kingdom
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