Quality Assurance Regulatory Affairs Manager - IDOVEN

They are looking for a Regulatory Affairs and Quality Assurance (RAQA) Manager who will be responsible for compliance to international quality and regulatory requirements.

About IDOVEN

IDOVEN is redefining cardiology with AI-powered research and diagnostic tools. We are invested by top VCs and business angels.


Our technology is recognised with the European Seal of Excellence, funded by the Horizon 2020 European Commission, supported by EIT Health (network of best-in-class health innovators backed by the EU) and received the Healthy Longevity Catalyst Award from the U.S. National Academy of Medicine.


In 2021, we are awarded in South Summit as Most Disruptive Startup and Best Health Startup. We are one of the most promising European technology companies to watch. Come join us!


We are looking for a Regulatory Affairs and Quality Assurance (RAQA) Manager who will be responsible for compliance to international quality and regulatory requirements.


What you will do

- Responsible for completing the submissions, technical files and other regulatory dossiers.

- Support and implement regulatory strategy and oversee the execution of this roadmap.

- Keep up to date on current regulations that affect our products.

- Review labels, literature, collateral and claims as requested.

- Provide regulatory guidance to multiple teams (data, medical, engineering, business, legal) to ensure compliance with requirements.

- Design clinical validation studies that demonstrate cost-effectiveness, improved outcomes and appropriate risk-benefit assessment.

- Review competitive regulatory intelligence and provide update to team.

- Register products with health authorities.


What you need to succeed

- Extensive experience working as a Regulatory Affairs professional in the software as a medical device industry (a huge plus if it is in Artificial Intelligence and/or cardiology).

- Hands-on experience in co-ordinating successful regulatory submissions for class II medical devices in Europe and US (experience on and class III medical devices and more territories are highly appreciated).

- Superb knowledge of MDD/MDR, 21 CFR part 11 and part 820.

- Technical file authoring experience (CE mark, FDA 510(K) and PMA).

- Strong knowledge of ISO 13485, ISO 14971, ISO 15223, IEC 60601, IEC 62304, and IEC 62366 (a huge plus if complementary knowledge in ISO 27001/17/18/701)

- Ability to review, explain and apply regulations.

- Excellent organisation skills, attention to detail and ability to work on several simultaneous projects with tight timelines.

- Excellent verbal and written communication skills, including the ability to explain regulation to non-experts, techs, clinicians and business leaders.

- Excellent level of English, both written and spoken (Spanish and a third language is highly appreciated).

- Nice but not mandatory: RAPS certification (Regulatory Affairs Professionals Society).

- Experience in both corporate and startups is more than welcome.


Benefits:

🚀 Be part of one of the most disruptive startups in Europe.

🔆 Flexible working hours.

🔝 Remote friendly.

🎊 Paid time off on your birthday and your children's birthday.

🍒 Fresh fruit every week.

📚 Free books rental.

🙋 Training Budget.

❄️ Change of work schedule to work in the afternoon on ski powder days or after an epic snowfall.

🍻 Friday happy hours after our weekly team meetings.

😎 Regular team building events and offsites

🙀 Bank holidays swap inside the same month.


At IDOVEN, we believe in hiring people like you - ambitious, forward thinkers who want to make a difference in the world. Apply now!