Compliance Associate - London, United Kingdom - Thriva

Description

At Thriva, we're constantly trying new things to understand how we can improve people's lives by
putting better health in their hands with
tools they can trust, advice that they can action, and the support to get them there.

We're rated as the
best preventative health tech startup on Trustpilot, and we're only just getting started.

We're scaling fast and working hard to offer people the best level of understanding, support, and tracking throughout their health journey.

Thriva was the
7th fastest-growing business in Europe in 2021, and we also recently ranked
3rd on the Sunday Times 100 list of Europe's fastest-growing companies.

We're on a mission to help millions of people worldwide actively invest in their health. We make diagnostic services and the powerful data they provide easy to access, intuitive to action and affordable. We do this via both our b2c and b2b channels.
If you would like to be part of the team helping to give people more years of life in great health, we'd love to hear from you


The role:

We are looking for a
Compliance Associate to join the Legal and Compliance Team at Thriva.

We have a IVD and a SaMD product currently in the GB market with expansion plans to sell in the EU in the near future.

Reporting to the Head of Regulatory Affairs, the post holder will assist the Regulatory and Quality team within the Legal & compliance department in ensuring that the necessary processes are implemented, evaluated and maintained in compliance with the requirements of the appropriate ISO standards and regulations.

We currently have ISO13485 and ISO27001 accreditations.


Main Responsibilities:

• Maintain document control, nonconformance and corrective and preventative action systems in relation to both ISOs.

- review ISO documentation with each department on a rotational basis to assess compliance and support continuous improvement

• Bring internal crossfunctional alignment as a project manager ahead of external audits to ensure successful outcome
• Assist in maintenance of existing technical files and preparation of new technical files ahead of new product launches
• Prepare and/or review draft SOPs/Records/protocols/reports as needed.
• Communicate with suppliers, contract manufacturers and internal departments for any document issues.
• Assist in running regular key meetings covering risk and compliance
• Help to continually manage risks and demonstrate continuous improvement
• Work crossfunctionally and collaboratively to raise the profile of compliance team across the organisation

Qualifications:

• Bachelor's degree or equivalent experience in a relevant field
• Proven experience within a digital health/medical device/IVD company
• Basic understanding of medical devices standards and regulations
• Basic knowledge of ISO27001 or other information security practices
• Experience in Project management
• Strong analytical and critical thinking skills
• A keen eye for detail and a resultsdriven approach
• Outstanding communication and technical writing skills

How we work:
We work in a hybrid way and offer flexible working options.

Our office in Old street is open for anyone who wants to go in - whether you find the office is the best place to work and want to come in frequently; or you enjoy a change of scenery and are meeting your team weekly or monthly.

We want to help you do your best, be yourself, and ultimately never have that "Sunday fear", here are some of our perks:

• Employee option scheme
• 28 days holiday (plus bank holidays)
• 6week paid sabbatical on your 4year Thrivaversary
• Wellbeing budget, from a mindfulness app subscription, to childcare, a new hobby or a massage, you choose how you want to spend it
• Private healthcare with Bupa
• Nursery scheme
• Income protection & Life insurance

- £600/year professional development budget

• Free Thriva tests
• 2 days paid voluntary / charity / community work
• Pet friendly office
• Climate perks programme
• 8 weeks work from anywhere per year

We embrace diversity at Thriva.

To build a product that is loved by everyone 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.