For over 25 years, Surgical Innovations has proudly designed, developed and manufactured high quality, precision engineered instruments from our Head Office in Leeds. SI are a leading UK manufacturer of medical devices for minimally invasive surgery.
As the main trading arm of Surgical Innovations Group Plc., which is listed on the Alternative Investment Market (AIM), we currently employ over 60 staff in our 32,000 sq.ft. space. Which houses an extensive machine shop, two clean rooms, injection moulding, warehousing and office space.
SI is also proud to work with other leading medical device companies on an OEM basis to design and manufacture medical devices bespoke to their needs. We have also transferred our technologies, which are designed to access small spaces with ultimate precision, into the industrial market.
Key to our success is our team of employees. We place great value on our mutually respective relationships with employees, and seek to identify, nurture and retain talent. We offer a competitive benefits package, continuous training and development opportunities.
We are looking for talented people who share our vision and to join our team. Please see below for any jobs we currently have available.
We are always looking for new talent, if you think you have what we’re looking for, please contact: si@surginno.co.uk
Regulatory Specialist / Associate
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Reports To: QA/RA Manager
General Overview of the Role
The main focus of the role will be to work on the regulatory requirements of the business, especially by working to meet corporate objectives and contribute to growth of the business. From time to time, the role may require participation in areas of quality to ensure efficiency of business activities, continuous improvement and compliance.
Duties and Responsibilities
Key regulatory duties:
- Managing global product registrations in accordance with country-specific regulations
- Contribute to the development and maintenance of standard and custom product information responses in various formats to address registrations and customer requests
- Updating relevant global, regional and local databases to ensure compliance.
- Organise and maintain reporting schedules for regulatory actions i.e licence renewal
- Participate in compliance gap analyses, implementation planning, and project management to ensure compliance with applicable regulatory requirements.
- Determining regulatory pathways for various global regions
- Assisting/advising with the preparation of technical documentation to meet regulatory submission requirements
- Assisting project teams to complete regulatory submissions.
- Ongoing Implementation and maintenance of the Vigilance and Post Market Surveillance process(es) to ensure compliance with global requirements.
- Leading on and writing post market surveillance reports
- Writing and maintenance of Technical Files as required
- Writing clinical evaluation reports
- Developing and implementing processes for the QMS for control of regulatory activities as required.
Any other duties as assigned by Management
Required Skills, Experience and Education
Skills/Experience
- Effective communicator with good interpersonal skills
- Customer oriented/focused and able to develop and maintain good customer relationships
- Well organised and able to manage documentation
- Plans, schedules, and completes tasks/projects to meet deadlines and corporate objectives
- Able to work in a cross-functional team
- Commercially Aware
- Knowledge/understanding of FDA regulations including 21 CFR 820, EU Medical Device Directives, Canadian Medical Device Regulations and other international regulations.
- Knowledge of the requirements for international quality systems, including ISO 13485 and 9001 required
- Relevant experience in the Pharmaceuticals/Medical Devices Industry
Education
Minimum of a Bachelor’s Degree required, preferably in a Science or Engineering field.
Desirable Skills/Education
- Proficiency in a second language
- Professional certifications (eg.RAPS)
If you would like to find out more about this role please forward questions along with your CV to shazia.chaudhry@surginno.co.uk
No Agencies Please.
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