Regulatory Affairs Officer - FTC

SPD Development Company Ltd; Bedford; Hybrid; GBP 25,000 - 31,000; Full time

Benefits offered by this job

Hybrid working

Job summary

Swiss Precision Diagnostics GmbH (SPD) in Bedford is seeking a Regulatory Affairs Officer – FTC to join our team on a 12-month fixed-term contract. The role combines administrative duties with preparation of documents to support regulatory initiatives and device registrations.

You will work at our Innovation Centre in Bedford with hybrid working options, handle confidential information, and interact with internal and external stakeholders ensuring quality systems alignment and precise regulatory

Qualifications

• Experience handling confidential information and understanding of quality systems (GMP/ISO).
• Strong written and oral communication skills with attention to detail.
• Ability to engage effectively with internal and external stakeholders.

Responsibilities

• Based at the Innovation Centre in Bedford with hybrid working option.
• Prepare documents to support regulatory initiatives and device registrations.
• Assist with regulatory surveillance tasks and monitoring activities.
• Represent the company to high professional standards with excellent interpersonal skills.

Skills

Attention to detail

Written and verbal communication

Stakeholder engagement

IT literacy

Quality systems knowledge

Job description

Regulatory Affairs Officer – FTC

Salary: £25,000 – £31,000 /annum DOE plus benefits

Location: Bedford

Full-Time, Fixed-Term for 12 months

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 the world over as providing accurate home pregnancy and fertility monitoring tests.

Responsibilities

• Will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.
• This is an excellent opportunity for someone looking to take their first steps into working within a Regulatory Affairs department. The role will include both administrative tasks as well as preparation of documents to support regulatory initiatives within the department.
• The role will also help with device registration activities and track regulatory surveillance tasks.
• We’re looking for someone who is highly literate and numerate with a keen eye for detail and a passion for accuracy in written work.
• Applicants will have the ability to engage effectively with a range of stakeholders, both within and outside the organisation, and be able to demonstrate this.
• 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.
• Previous experience in the handling of sensitive and confidential information is essential along with the understanding of the need for current Quality System / GMP / ISO compliance.
• Having a high level of IT literacy is essential and the ability to use standard and bespoke software applications would be advantageous.

What we can offer you:

• Hybrid working
• 25 days paid annual leave plus bank holidays (pro-rata)
• 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 and Wellbeing programme
• Life assurance
• Free electrical car charging points
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and 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

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.