Senior Regulatory Affairs Associate

6 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

  • Regulatory Affairs Professional

    3 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    Job SummaryWe are seeking an experienced Regulatory Affairs Associate to join our team at Entrust Resource Solutions. This role offers the opportunity to work across global markets, with a focus on medical devices and diagnostics.The ideal candidate will have a strong understanding of EU and international regulatory requirements, as well as experience in...

  • Global Regulatory Compliance Associate

    2 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    Job Summary:We are Entrust Resource Solutions, a leading medical device company based in Scotland. Our current growth trajectory has led us to seek an experienced Regulatory Affairs professional to join our team as a Senior Regulatory Affairs Associate.About the Position:The successful candidate will be responsible for regulatory affairs activities,...

  • Senior Regulatory Affairs Associate

    6 days ago

    Leeds, United Kingdom Disability Solutions Full time

    Johnson & Johnson MedTech is currently seeking a Senior Regulatory Affairs Associate.Location: Leeds Office, (hybrid model, 3 days in office 2 at home)\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are...

  • Regulatory Affairs Specialist I

    7 months ago

    Leeds, United Kingdom Johnson & Johnson Full time

    **Regulatory Affairs Specialist I** **DePuy Synthes - Joints** **Location - Office Based, Wokingham or Leeds** For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our...

  • Regulatory Affairs Specialist

    1 day ago

    Leeds, United Kingdom Medella Life Full time

    Job Title: Regulatory Affairs Specialist (12-month Contract)Location: Hybrid - Cambridge, UKOverview: We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team on a 12-month contract basis. The successful candidate will play a crucial role in ensuring regulatory compliance within the Medical Device sector, with a focus...

  • Regulatory Affairs Professional

    3 weeks ago

    Leeds, Leeds, United Kingdom The Health & Safety Partnership Careers Full time

    If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we invite you to apply for the position of Building Control Surveyor Expert at The Health & Safety Partnership Careers. As a key member of our Compliance team, you will play a vital role in ensuring that all projects meet the required Building Safety Act and Building...

  • Regulatory Affairs Expert

    2 weeks ago

    Leeds, Leeds, United Kingdom CV Library Full time

    Regulatory Affairs ExpertCV Library is seeking a Regulatory Affairs Expert to join our team. As a key member of our team, you will be responsible for ensuring compliance with regulations and standards in mechanical engineering.About the RoleYou will work closely with engineers and other stakeholders to ensure that our products meet regulatory...

  • Regulatory Affairs Professional

    4 weeks ago

    Leeds, Leeds, United Kingdom The People Co. Full time

    The People Co. is seeking an experienced Regulatory Affairs Professional to join our compliance department. In this role, you will be responsible for managing risk by ensuring the accuracy of our product information, including audit reports and certifications.You will maintain awareness of customer, food legislation, and legal changes, updating our policies...

  • Senior Regulatory Affairs Specialist

    6 days ago

    Leeds, Leeds, United Kingdom William Hill Full time

    Job Description:We're looking for a Senior Regulatory Affairs Specialist to join our UK team. This role requires expertise in ensuring our operations meet regulatory requirements and providing strategic advice on compliance risks and opportunities.">Develop and enforce compliance policies and procedures to ensure adherence to UK and Gibraltar...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom CV-Library Full time

    We are seeking a Regulatory Affairs Specialist to join our team at CV-Library in Leeds, West Yorkshire. As a Regulatory Affairs Specialist, you will be responsible for ensuring the firm's compliance with all relevant statutory laws and regulations. This includes managing the firm's Lexcel Accreditation Audit, monitoring and reviewing compliance procedures,...

  • Regulatory Affairs Specialist II

    6 days ago

    Leeds, Leeds, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Job OverviewThe company is recruiting for a Regulatory Affairs Specialist II to support our Sports Orthopedics business. This role will follow a Flex/Hybrid schedule with 3 days per week in the office.This position provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Arthroscopic Equipment...

  • Regulatory Affairs Expert for Global Medical Devices

    2 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    Company Overview:Entrust Resource Solutions is a renowned medical device company based in Scotland, currently expanding its operations globally due to high demand for its innovative products.Job Description:We are seeking an experienced Senior Regulatory Affairs Associate to join our team. This role offers exposure to various regulatory areas and the...

  • Regulatory Affairs Professional

    6 days ago

    Leeds, Leeds, United Kingdom The Oval Partnership Full time

    About The Job:We are seeking a highly skilled Regulatory Affairs Professional to join our technical team at The Oval Partnership. As a key member of the team, you will be responsible for ensuring that all raw materials meet the required standards and are in line with regulatory requirements and business policies.Main Responsibilities:To review and analyze...

  • Senior Regulatory Specialist for Medical Device Industry

    2 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    About Us:Entrust Resource Solutions is a Scottish-based medical device company that has achieved significant success over the past 12 months, culminating in FDA approval and the opening of overseas manufacturing sites. Due to this growth, we are now seeking an experienced Regulatory Affairs professional to join our team.The Role:As Senior Regulatory Affairs...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    Discover a career opportunity with Entrust Resource Solutions, a Scottish-born medical device company that is going global due to high demand for their product. As part of their growth, they are seeking an experienced regulatory professional with relevant medical device or similar experience. This role offers exposure to several regulatory areas and the...

  • Regulatory Affairs Manager

    2 weeks ago

    Leeds, Leeds, United Kingdom BCL Legal Full time

    We are seeking a Regulatory Affairs Manager to join our Environment, Health and Safety team in Leeds. As a key member of the team, you will provide expert advice on environmental and health & safety matters, ensuring compliance with relevant regulations and industry standards.About the RoleYou will be responsible for developing and implementing regulatory...

  • Solicitor in Regulatory Affairs

    2 weeks ago

    Leeds, Leeds, United Kingdom G2 Legal Limited Full time

    Solicitor in Regulatory AffairsWe are looking for a highly skilled Solicitor to join our Health & Care Regulatory team in Leeds. This role offers a unique opportunity to work on a wide range of health, social care, and education issues, both contentious and non-contentious.The successful candidate will manage complex litigation, provide advocacy services,...

  • Global Regulatory Compliance Professional

    2 weeks ago

    Leeds, Leeds, United Kingdom Entrust Resource Solutions Full time

    Are you a highly skilled regulatory professional looking to take your career to the next level? Look no further than Entrust Resource Solutions, a dynamic company that is expanding its operations globally. As a Senior Regulatory Affairs Associate, you will play a crucial role in ensuring the compliance of the company's medical devices with international...

  • Regulatory Affairs Professional

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist II to join our team in supporting the commercialization of medical devices. This role will be based in the UK, but may require occasional travel to other locations.About the RoleThe successful candidate will provide regulatory guidance to project teams, develop and perform regulatory...

  • Regulatory and Governance Affairs Officer

    1 week ago

    Leeds, United Kingdom University of Leeds Full time

    **Regulatory and Governance Affairs Officer**: **We are looking for a Regulatory and Governance Affairs Officer to play a key role in the Quality Assurance department of a large nationally leading clinical trials unit.** - ** Do you have excellent knowledge of UK regulatory and governance requirements relating to clinical trials research?**: - ** Do you...