Regulatory Affairs Specialist - Innovation

SPD Development Company Ltd; Bedford; Hybrid; GBP 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid working

Annual discretionary bonus

25 days annual leave + bank holidays

Pension scheme

Private Medical Insurance

Parental pay

Health & Wellbeing programme

Life assurance

Electric car charging points

Job summary

SPD Swiss Precision Diagnostics GmbH seeks a Regulatory Affairs Specialist - Innovation to join the Regulatory Affairs team at the Bedford Innovation Centre, with hybrid working options. The role focuses on regulatory strategies for new product development in the IVD/Medical Device space and involves collaboration with cross-functional teams and external bodies.

Ideal candidates hold a BSc in life sciences and have hands-on regulatory experience, knowledge of ISO 13485, IVDR/MDR, and FDA

Qualifications

• Hands-on regulatory experience in IVD or medical devices.
• Strong written and verbal communication in English.
• Ability to work with Notified Bodies and regulatory authorities.

Responsibilities

• Develop and execute regulatory strategies for new product development.
• Support market access and regulatory submissions for IVD/MD products.
• Provide regulatory guidance to cross-functional teams throughout the project lifecycle.

Skills

Regulatory knowledge

Communication skills

Cross-functional collaboration

Education

BSc degree

Job description

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 between Procter & Gamble (P&G) and Abbott; and our brand Clearblue, is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Specialist - Innovation to join our Regulatory Affairs team on a Full-Time, Permanent Contract.

The role will be based at our Innovation Centre in Bedford, UK with an option for Hybrid Working.

The Regulatory Affairs Specialist role supports the development and execution of regulatory strategies for new product development projects and business development opportunities as directed by the Regulatory Affairs Manager - Innovation and the Global Regulatory Director.

The role fundamentally provides technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). 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 teams and supports the identification of compliant, practical and efficient solutions to regulatory challenges.

We're looking for someone who holds a minimum of BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has hands‑on experience in the IVD or Medical Device Industry. The role holder should have good working knowledge of ISO 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 with Notified 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.