Regulatory Affairs Specialist - Innovation
Location: Bedford
The Vacancy
Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture betweenProcter & Gamble (P&G) andAbbott; and our brandClearblue, is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests.
We are looking for aRegulatory Affairs Specialist – Innovationto join our Regulatory Affairs team on aFull-Time, Permanent Contract.
The role will be based at our Innovation Centre inBedford, UK with an option forHybrid Working.
The Regulatory Affairs Specialist role supports the development and execution of regulatory strategies for new product development projects and business development opportunitiesas directed by the Regulatory Affairs Manager – Innovation and the Global Regulatory Director.
The role fundamentallyprovides technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). A As part of this, the role supports regulatory strategy implementation, market access activities, regulatory intelligence and surveillance activities, and the assessment of emerging regulatory requirements, standards and industry trends.
The role supports innovation projects from concept through to commercialisation, including third party sourcing opportunities. Working alongside the Regulatory Affairs Manager – Innovation, the role provides regulatory guidance to cross functional teamsand supports the identification of compliant, practical and efficient solutions to regulatory challenges.
We’re looking for someone who holds a minimum ofBSc degree or equivalent experience in life sciences(e.g. biological sciences, biochemistry, pharmacology etc.) and has hands-on experience in theIVD or Medical Device Industry. The role holder should have good working knowledge ofISO 13485, IVDR (EU 2017/746), MDR (EU 2017/745) and FDA regulations for medical devices, and other international standards and regulations for IVD and medical device products. Experience of working withNotified Bodies and Regulatory Authorities, supporting product development activities and preparing regulatory submissions and technical documentation would be highly advantageous.
The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly.
We can offer you:
- Hybrid working
- Annual discretionary bonus
- 25 days paid annual leave plus bank holidays
- Company pension scheme including competitive employer’s contribution
- Private Medical Insurance package with additional medical cash plan scheme
- Enhanced maternity and paternity pay
- Company supported employee Health & Wellbeing programme
- Life assurance
- Free electrical car charging points
- Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail)
If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.
We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.
The Company
SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.
Our SPD research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.
Interested
Click apply and you will be redirected to our careers page to complete your application.
:quality(80))
:quality(80))
:quality(80))