Quality and Regulatory Affairs Specialist

Quality and Regulatory Affairs Specialist

Start: asap

Location: Cambridgeshire

Salary: £40-45k

Hours: 37.5 hours Monday To Friday

Reporting to the QRA Manager, the Quality and Regulatory Affairs Specialist (QRA Specialist) ensures in-vitro diagnostic product registrations, oversees post-market surveillance, and maintains regulatory compliance.

Duties:

• Provide Quality and Regulatory expertise.
• Track regulatory changes and analyse their impact.
• Support internal training and interpret regulatory requirements globally.
• Prepare high-quality technical documentation for submissions and responses.
• Review and approve product labeling and promotional material.
• Manage regulatory compliance for post-market activities.
• Conduct impact assessments for changes raised internally and by contract manufacturers.
• Assist in internal and external audits.
• Analyse product and system data, preparing relevant reports.
• Actively participate in continuous improvement efforts.
• Build strong relationships for regulatory compliance and audit readiness.

Essential Skills/Experience/Education:Knowledge and Experience:

• Bachelor’s degree in scientific, engineering, regulatory, pharmacy, legal, or quality.
• Minimum three years' IVD experience.
• Knowledge of ISO 13485:2016, ISO 14971:2019, QSR, IVDD, and IVDR.
• Proven experience in process/procedure/QMS development and implementation.

Skills:

• Driven, proactive, and passionate about Regulatory Compliance.
• Proficient in data-driven problem-solving.
• Risk-based decision-making ability.
• Strong interpersonal and independent working skills.
• Excellent written and verbal communication.
• Ability to work under pressure and meet deadlines.
• Attentive to detail.
• Influential team player, maintaining QARA team credibility.

Desirable Skills:

• Experience in molecular instrument-based IVD platforms.
• Familiarity with contract manufacturers.

If you are interested in the role of Quality and Regulatory Affairs Specialist and feel that you have the relevant experience, please contact your Recruitment Partner, Lisa Logan at Unicorn Resourcing on (phone number removed) or email (url removed)

If this job isn't exactly right for you but you're looking for something new, please contact us for a confidential career discussion.

Unicorn Resourcing Limited is acting as an Employment Agency in regard to this Permanent opportunity.