Medical Device Regulatory Expert (RegTech Startup)

RegMetrics is a regulatory compliance software solution for medical devices. Our mission is to simplify the regulatory journey, saving MedTech innovators and academics time and money while helping bring life-changing medical devices to market. We are seeking a passionate and experienced Medical Device Regulatory Expert to join our growing team on a part or full-time basis to help us make regulation fun!

Role Overview

We are seeking a highly skilled and experienced Medical Device Regulation Expert to join our dynamic team. As a key member of our regulatory team, you will play a pivotal role in digitising the regulatory pathway and provide advice to clients.

Responsibilities

Regulatory Expertise:

  • Provide in-depth knowledge and expertise in EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
  • Stay up-to-date with the latest regulatory developments and industry best practices.
  • Interpret and apply complex regulatory requirements to diverse medical devices.

Platform Development:

  • Support the product development team to digitise the regulatory pathway while enhancing the functionality and keeping the accuracy of RegMetrics.
  • Provide regulatory content for RegMetrics.
  • Work with the product team to ensure that RegMetrics user interface is intuitive and easy to use for people with no regulatory knowledge.

Client Consultation:

  • Provide expert consultation to university and medtech startups on regulatory compliance matters.
  • Conduct regulatory gap assessments and risk analyses to identify potential compliance issues.
  • Offer strategic advice on regulatory strategies and regulatory pathways using RegMetrics.

Training and Education:

  • Develop and deliver training programs on MDR and IVDR regulations for our customers.
  • Create educational content, such as webinars, whitepapers, and blog posts, to raise awareness of regulatory issues.

Qualifications and Experience:

  • Advanced degree in engineering, life sciences, or a related field.
  • Extensive experience in medical device regulation, with a focus on MDR and IVDR.
  • Strong understanding of regulatory requirements for various device classifications.
  • Proven track record of providing regulatory guidance and support to medical device companies.
  • Have been involved in Notified Body audits.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills, both written and verbal.
  • Ability to work independently and collaboratively within a fast-paced, dynamic team.

Benefits

  • Part-time basis with an annual salary range of between £40,000 to £55,000.
  • Preferably having the right to work in the UK. European citizens may be considered as well.
  • Opportunity to work on cutting-edge technology and make a significant impact on the MedTech industry.
  • Flexible working arrangements mostly working from home.
  • Potential for career growth and development.
  • Three (3) month probation period.

Please apply before 5pm, 22. January 2025.

If you are a passionate and results-oriented professional who is excited to join a dynamic startup, we encourage you to apply. Please submit your Resume and Cover Letter to Rita Hendricusdottir (rita.hendricusdottir@reg-metrics.com) and Sam Barton (sam.barton@reg-metrics.com).