Regulatory Affairs Specialist

3 weeks ago

Cambridge, United Kingdom Biocrucible Full time

Sapphiros UK, a pioneering force in medical technology, is on the brink of a new era as we launch groundbreaking products into the market. As we embark on this exciting journey, we are actively seeking an experienced Regulatory Affairs Specialist to join our small but growing team. This is a unique opportunity to be at the forefront of cutting-edge developments in consumer and near-patient diagnostics and, shape your role within.

**Role Overview**:
This role is tailor-made for an ambitious professional ready to elevate their career. In 2024, we have ambitious regulatory goals, and you will be instrumental in designing and implementing regulatory and post-market procedures across all entities. As we release new products, your role will involve managing the actions required from these procedures. Additionally, you will play a pivotal role in implementing IVDR/MDR across our entities.

Day to day, you will collaborate with Commercial, R&D, Quality, and Operations teams, providing input on regulatory strategy, requirements, and aiding in the design, manufacture, and sale of compliant products. While focusing on post-market activities, you will have the opportunity to specialise in other areas, such as specific product types, country-specific regulations, or other regulatory processes like regulatory intelligence or planning for design.

**Roles and Responsibilities**:
**Medium-term projects**:

- Support the development and implementation of post-market procedures, regulatory procedures across all Sapphiros entities.
- Support and potentially lead IVDR Implementation.
- Write technical documentation for product registrations in the UK, EU, and US.

**Job roles**:

- Manage post-market regulatory compliance.
- Develop, implement, and maintain procedures enabling compliance with applicable global regulations and standards, including ISO 13485:2016, MDSAP, 21 CFR 820, and EU IVDR/MDR.
- Review product labeling and promotional material.
- Provide regulatory guidance to design and development projects.

**Preferred Experience and Skills**:

- 2-3 years of professional experience in regulatory affairs or quality management systems related to medical devices (preferably experienced with IVDs).
- Working knowledge of EU IVDR (or MDR), ISO 13485. Helpful to have experience in US, Canada regulations.
- Experience in drafting technical documentation included in product registrations.

**We value our team members and offer a comprehensive benefits package, including**:

- Healthcare coverage, encompassing optical, dental, and worldwide travel.
- Generous annual leave of 25 days, with an additional 3 days off for Christmas celebrations.
- Life insurance for financial security and peace of mind.
- Employee Assistance Programs to support your well-being.
- Pension plan for a secure future.
- Income protection to safeguard against unforeseen circumstances.
- Enhanced sick leave provisions, ensuring your health and recovery are prioritised.
- Outstanding parental leave policies, supporting you during important life moments.

**About Us**: Sapphiros UK is the fusion of two innovative entities - Biocrucible in Cambridge and Flexotronix in Hove. Biocrucible specialises in molecular detection technologies for near-patient and at-home testing, while Flexotronix is a center of excellence in high-speed printed electronics manufacturing. Together, they form Sapphiros UK, a company committed to pushing the boundaries of what's possible.

**We look forward to speaking with you.

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