Clinical and Regulatory Lead

A bit about us

We're Doccla, the virtual ward company. We provide patients and clinicians with the transformative power of remote patient monitoring.

Our existing customers are Hospitals, Community Services, and NHS Commissioners that we partner with to deliver tech enabled virtual wards. With our technology, logistics, and support patients can be discharged from a hospital ward to a virtual one and recover in the comfort of their own homes. Patients love our care pathways and health services become more efficient; it's a win-win.

Doccla is a growing health tech startup; we have secured a £35ml at Series B, led by European VC Lakestar, with new investors French VC Elaia and existing investors General Catalyst, Speedinvest and the investment leg of German media company Bertelsmann also participating. We're solving real problems for patients and health systems and we are growing at exceptional speed. We're looking for dedicated people with a passion for solving the problems in healthcare.

This is your chance to join us at a key stage of our growth. Our ambition is to be a category leader for virtual healthcare. You will be joining a highly entrepreneurial team that combines technical, clinical, operational, and commercial colleagues.

Job title

Clinical and Regulatory Lead

Department

Research And Regulatory Strategy

Job Summary

The Clinical and Regulatory Lead will lead the development and validation of Software as Medical Devices, particularly in the area of remote patient monitoring and telemonitoring, using rigorous clinical validation and innovative research initiatives. The role involves design, execution and oversight of clinical investigations, collaboration with healthcare, academic, and industry partners, and ensuring compliance with EU and UK medical device regulations, including MDR 2017/745 and UK MDR 2002 (UKCA). This position will also focus on regulatory submissions, clinical evaluations, and post-market surveillance.

Key Responsibilities

1. Lead the design and execution of clinical studies or service evaluations, ensuring safety, efficacy, health and economics outputs of telemonitoring devices in line with MDR 2017/745, ISO 14155, and healthcare organisations (e.g., NICE) guidelines.
2. Lead the creation and updates of regulatory documentation, including Clinical Evaluation Plans (CEP) and Clinical Investigation Plans (CIP), ensuring compliance with MDCG guidelines and other relevant regulatory frameworks such as the UKCA. This to be done in close collaboration with the Regulatory Affairs and Quality Assurance team.
3. Engage with Health Innovation Networks, academic institutions, and clinical research organisations across Europe to foster partnerships and drive innovation in telemonitoring solutions.
4. Collaborate with global healthcare and research organisations to generate clinical evidence, support regulatory submissions, demonstrate device safety and performance, and publish high-quality peer-reviewed publications.
5. Ensure the ongoing collection of clinical evidence through post-market clinical follow-up (PMCF) activities in compliance with MDR 2017/745 and other relevant standards.

About you and experience

1. Education: Advanced degree in Medicine, Science, or related fields.
2. Experience: Minimum 4 years of experience in digital health, medical device regulatory affairs, and clinical operations, with a strong focus on compliance with MDR 2017/745 and UK MDR. Experience in large-scale clinical trials and medical device evaluations is essential. Proven experience in interacting with notified bodies and competent authorities.
3. Skills: Proven expertise in managing clinical investigations, medical device regulatory submissions, clinical evaluations, and knowledge of EU and UK regulations including MDR 2017/745. Familiarity with ISO 13485 is desirable.
4. Strong leadership, project management, and communication skills are essential.

Don't worry if you don't have all of the skills outlined on a job advert, we value diverse skill sets, and recognise that no one candidate will match all desired skills - we'd love to hear from you if you think a role seems like an interesting opportunity for you!

How we work

We empower everyone to take ownership and responsibility for the company and their role within it. We act ethically and think of helping patients and protecting their safety first.

Whatever your role is, to thrive at Doccla, a can-do and action oriented attitude is essential. As is being a clear and open communicator who is receptive to feedback.

Our team is hybrid with offices in London, Denmark, Germany & Stockholm. Most of the team lives in and around London and visits the office one to three times per week to enjoy in person meetings, free lunch with the team, and the general perks of a WeWork with a glorious barista. The extent of remote vs office working will depend on your role, as some roles have the flexibility to be fully remote.

Employee Benefits

1. Annual Leave & Holidays:
   • 25 days of annual leave plus up to 8 bank holidays per year.
   • Flexibility to buy or sell holidays back to the company.
2. Remote Working:
   • Flexible Remote Work: Options to work remotely, giving you the freedom to balance work and life.
   • Home Office Setup: £200 remote working stipend to enhance your home office.
3. Financial Benefits:
   • Employee stock options.
   • 4% pension on full basic pay.
   • 4x basic pay for Life insurance.
4. Health & Wellness:
   • Private health insurance.
   • 4 months full pay for the birthing person.*
   • 4 weeks full pay for the non-birthing person.*
   • Sick pay.
5. Workplace Perks (if not remote):
   • Daily lunch provided at HQ.
   • £500 Learning & Development budget per employee.
   • Cycle to work scheme.
   • Pet-friendly office.

What do you get for all your hard work?

1. A competitive compensation package (base + options) with half year and annual performance reviews.
2. Work at one of the most patient focused and client centric healthtech startups, backed by top VC firms, General Catalyst & Speedinvest.
3. Growth. We want you to keep growing. That means trying new things, leading others, challenging the status quo and owning your impact. Always with our complete support.

Diversity at Doccla

We embrace diversity at Doccla. To build a product that is valued we need a team with all kinds of different perspectives, experiences and backgrounds. That's why we're committed to hiring people from different backgrounds, race, religion, national origin, gender identity, sexual orientation, gender identity, age or disability.

We understand that applying for a new job takes a lot of work and we really value your time. We are really looking forward to reading your application!

Safer Recruitment

Doccla is committed to the principles of safer recruitment, ensuring that safeguarding and promoting the welfare of children and vulnerable adults is central to our recruitment processes. A Disclosure and Barring Service (DBS) check will be required for all posts with access to children or vulnerable adults. Please note that it is an offence to apply, offer or accept to do any work with children (paid or unpaid) if disqualified from working with children.