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 approximately 80 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, and continuous training and development opportunities to ensure those joining us on our journey, grow too!
Surgical Innovations is a medical device manufacturer currently undergoing the final stages of MDR transition. The Technical Specialist will be the functional expert for activities relating to biocompatibility, risk management, usability, clinical evaluation plans, reports, post-market surveillance and dealing with clinicians to obtain user input and feedback into prepared documents.
Utilise information within regulations and available guidance documents to compose well-structured and logical technical content
Provide technical input and support to R&D projects
Manage Company knowledge (assimilate and disseminate) for the clinical area of business need, and the other related areas of the technical, regulatory, and research & development teams
Author/assist in writing technical documentation clearly, succinctly, and convincingly in an engaging manner, structuring detailed information to meet the needs of the audience
Conduct research utilising literature databases (e.g. Help to ensure activities are delivered in line with deadlines
Support risk management, usability, clinical, and post market documentation requirements in accordance with EU MDR and other applicable regulations
Bachelor’s Degree, as a minimum, including research projects in a Science or Engineering field
Knowledge/awareness of the requirements of ISO 13485:2016, EU Medical Device Regulations (MDR) and MDSAP
Awareness of multinational regulatory strategy, collaboration with internal and external stakeholders, key opinion leaders and regulators.
Project management skills (Work breakdown structure, basic Gantt charting, communication plan) to manage regulatory projects
The role offers a competitive salary of £30,00 to £35,000 (dependent on experience), and a range of benefits including a 9-day working fortnight (every second Friday off), pension, bonus, life assurance, private medical, income protection, health cash plan, perkbox, and free parking.