Are you a regulatory affairs professional with experience of the regulatory landscape of medical devices or in-vitro diagnostic devices? Do you want to be a part of building a medical device quality management system in a global organization at the forefront of life sciences and healthcare?
Blueprint Genetics is one of the fastest growing clinical genetic testing companies for inherited diseases globally. We work with hundreds of clinics around the globe and the quality of our interpretation has been praised by many of the world’s best medical centers. As our company continues to grow, we are looking for a full-time Senior Regulatory Specialist to join our Quality Assurance and Regulatory Affairs team in Espoo, Finland
We are looking for you, who wants to make a difference
As a Senior Regulatory Specialist, you will be developing and maintaining registration, conformity assessment, post-market and vigilance processes to meet relevant medical device regulations, including the new EU IVDR and MDR regulations. You will work closely with several teams and experts across the organization to ensure that our offering and processes are in compliance with relevant customer and regulatory requirements. You will be actively driving the change and strengthening a culture of quality at Blueprint Genetics together with our Quality Assurance and Regulatory Affairs team.
Your main tasks will include:
- Developing and maintaining registration, conformity assessment, post-market and vigilance processes to meet relevant medical device regulations, including EU IVDR and MDR
- Collaborating with the Product Management team to ensure that our offering complies with relevant customer and regulatory requirements
- Supporting preparation and reviewing technical documentation
- Reviewing and approving labeling updates
- Supporting change management
- Supporting and participating in regulatory agency and customer quality audits
- Developing inspection methods to analyze product and service quality
- Performing data trend analysis to improve processes and products
- Supporting scientific, complaint, and other investigations
- Coordinating, in collaboration with other teams, nonconforming product and CAPA management to drive root cause analysis and practical corrective and preventive solutions
What we expect from you
We are hoping to find a team member who has strong expertise in EU IVDR and MDR regulations and takes ownership of the tasks at hand, but who is also eager to learn and grow with us. You address quality issues diplomatically and use your strong interpersonal skills to coach and support others. You are well-organized and can handle multiple priorities simultaneously. We hope you feel at home in a fast-paced working environment and fit the low-hierarchy and inclusive culture of Blueprint Genetics.
Our ideal candidate has:
- A BSc and/or MSc from the field of life sciences, engineering or law
- A minimum of 3 years of experience with medical devices quality assurance or regulatory affairs
- A solid understanding of applicable medical device regulations, including EU IVDR and MDR
- Knowledge of conformity assessment and pre-market activities, vigilance, risk management
- Excellent communication skills in English, both spoken and written
- Strong problem-solving and interpersonal skills
- Understanding of applicable regulations and industry standards regarding clinical laboratory, including ISO 15189, is an asset
What we offer
At Blueprint Genetics you will work with dedicated and innovative experts with versatile backgrounds, whilst having an opportunity to support industry-changing solutions that improve the lives of patients and families affected by inherited diseases. We offer you an open and collaborative work environment where you can learn and grow together with the company. You will join a growing team of five quality and regulatory experts.
If this sounds like you, please apply latest on Monday, May 10. We will be interviewing candidates on a rolling basis.
If you have any further questions about the position, you can contact our Quality Manager, Olli Mikkonen by email: email@example.com or by phone +358 40 846 8833 on April 22 at 13-16 (EET).