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 approximately 80 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, and continuous training and development opportunities to ensure those joining us on our journey, grow too!
Do you want to be part of an organisation that is leading the evolution in delivering sustainable and innovate solutions which advance healthcare? If so, we want to hear from committed and talented people like you, who share our vision and values to come and join our team.
About the Position
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.
Responsibilities
* Assist in the preparation of submissions for Auditing Organisations (e.g. BSI, FDA)
* 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
* Continuously review external guidance documents/regulations/standards etc. to ensure existing internal technical documentation remains state of the art
* Conduct research utilising literature databases (e.g. PubMed, ScienceDirect) and extract information relevant to Surgical Innovations devices to input into technical documentation
* 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
* Maintenance of electronic and physical records related to the function
Experience
The successful candidate will be able to demonstrate:
Essential
* 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
* Demonstrable ability to plan and deliver results within strict time constraints
* Awareness of multinational regulatory strategy, collaboration with internal and external stakeholders, key opinion leaders and regulators.
* Effective communicator with good interpersonal and presentation skills
* Commercially Aware and customer focused, ability to develop and maintain good customer relationships
Desirable
* Project management skills (Work breakdown structure, basic Gantt charting, communication plan) to manage regulatory projects
* Previous experience in compiling clinical evaluation reports to MDD or MDR requirements.
What We Offer
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.
If this sounds interesting and the right challenge for you, we look forward to receiving your application!