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Senior Regulatory Affairs Manager (Global)

By July 20, 2021No Comments

What you’ll be doing

In the role of Senior RA Manager, you will be supporting the organisation in regulatory submissions, device vigilance, regulatory intelligence and further developing the infrastructure to support the function.

You will interact with a variety of stakeholders including members of the Executive Team, functional department leads and technical/clinical staff as well as external consultants and regulatory bodies.

Joining us in this role, you will be part of a small agile compliance team, leading IVDR transition activities and leading regulatory submissions in UK, EU and US. You will be working at the forefront of genomic medicine and on a disruptive, ground-breaking product.

You will be able to influence and direct regulatory strategy and where applicable product strategy as a part of a multifunctional team. You will have an opportunity to shape the function and your role and to grow with the business.

Congenica’s Quality and Regulatory programme is recognised by investors as a competitive differentiator.

Ideally, when we return to the campus, we would like the person in this role to spend some regular time in the office. We are flexible to discuss what this might look like. However, for the right candidate we would consider a purely remote role.

Who we are

Congenica is a digital health company developing the gold standard in genomic interpretation platforms for accelerating analysis of rare diseases from genomic data. Simply put, we develop and operate a web-based service to accelerate the interpretation of complex genetic information with the goal of providing life-changing answers for individuals and their families.

Working at Congenica

You will make a real impact on the lives of people around the world with rare diseases. Our products and services enable healthcare professionals to accurately, confidently and rapidly analyse complex genomic data and improve health outcomes.

What will you be responsible for?

  • IVDR transition (product and relevant RA activities)
  • US FDA compliance activities
  • Device Vigilance
  • Mentoring staff on RA requirements of a regulated device
  • Developing appropriate infrastructure
  • Process improvement and strategic input

What skills, experience and qualifications do you need to succeed in this role?

 You will be the sort of person who is:

  • Open minded to different solutions
  • Open to assume something can be done even if there is no precedent.
  • Read situations and empathise with other departments with limited regulatory exposure.
  • Adaptable
  • Comfortable leading projects and taking ownership of activities.
  • Interaction with senior stakeholders.
  • Able to influence – credible – with an evidence-based approach.

Experience

  • Will have experience of regulatory submissions of Listed/Class C or D IVDs or IIa/IIb devices
  • Medical device software experience, this could be e.g. an instrument containing software and the instrument has a user interface (you would need to understand software Validation/Verification)
  • Will have US FDA regulatory experience.
  • Will have total Product Lifecycle experience
  • In previous roles will have experience of working with notified bodies
  • Will have worked on device vigilance.

Great to haves

  • MDSAP
  • China NMPA experience
  • Experience with SaMD, a stand-alone software medical device product
  • Ideally will have In Vitro Diagnostic industry experience
  • Professional certification e.g. RAPS, RAC
  • Range of Organisation experience e,g, Start Up, SME, Multinational

 

Congenica is dedicated to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

If this sounds like you and you’d like to join a growing company making a difference, then apply now!

 

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