Do you have experience with medical device or clinical lab regulatory affairs? Do you want to be part of a global organization at the forefront of life sciences and healthcare? If you answered yes, this position might be for you.
Blueprint Genetics, a Quest Diagnostics company is a clinical genetic testing company aspiring to bring genetic knowledge to mainstream healthcare to benefit patients with rare inherited diseases worldwide. We are looking for a full-time, permanent Regulatory Affairs Specialist to join us in strengthening our Quality and Regulatory team in Helsinki, Finland.
We are looking for those who want to make a difference
Regulatory compliance and continuous improvement play a crucial role in the growth and success of Blueprint Genetics. Our laboratory in Helsinki is FINAS (ISO 15189), CAP accredited and CLIA certified. We have also expanded our IVD medical device portfolio and have a permit for a laboratory in the State of New York. As a Regulatory Affairs Specialist at Blueprint Genetics you will have the opportunity to take on a wide range of responsibilities and work on exciting projects in a complex regulatory environment.
In this role, you will be responsible for ensuring compliance with applicable regulations, managing regulatory submissions and maintaining existing licensures, certificates and accreditations. With your regulatory expertise you will actively support our product development and product management teams in product registrations and execution of regulatory strategies. You will focus on supporting our operations in Europe, but you will also cooperate with our parent company Quest Diagnostics' counterparties in the US.
You will join a small and efficient Quality and Regulatory team and report to Regulatory Affairs Manager based in Finland. Together you will navigate in the world of scientific innovations and regulatory affairs and contribute significantly in our global mission to create healthier world, one life at a time.
Your main tasks will include:

• Prepare and maintain regulatory submissions (IVD medical devices and clinical laboratory)
• Maintain company's existing licensures, certifications, and accreditations
• Monitor changes in regulatory landscape and develop regulatory processes accordingly
• Participate in conformity assessment and vigilance processes
• Represent RA function in cross-functional teams and project groups
• Support product development, product management and other functions with RA-related questions
• Provide regulatory training and support
• Provide regulatory insights to customer questionnaires
• Support production teams on matters related to manufacturing, importing and distribution
• Conduct audits and participate in audits
• Create and update policies and procedures, document review
• Monitor key performance indicators, analyse data, and report results

Our expectations:
We are looking for a self-iniated colleague who wants to make an impact. You understand the regulatory landscape and you have the drive to find practical solutions to daily challenges. You can focus on details, without losing the sight of the big picture. We hope you have good interpersonal skills, and you can effortlessly collaborate with colleagues at all levels of the organization. Furthermore, you are well-equipped to work in a rapidly changing, global matrix environment, where ways of working and playbooks are evolving. Last but not least, we aspire to find a colleague who has the eagerness to learn and grow with us and who fits the inclusive and international culture of Blueprint Genetics and Quest Diagnostics.
Our ideal candidate would have:

• Bachelor's or Master's degree in life sciences, engineering, law or other relevant field of studies
• Working experience of 3 years in (IVD) medical device and/or clinical laboratory regulatory affairs
• Knowledge in IVDR or MDR is required, knowledge in FDA and clinical laboratory regulations is seen as an asset
• It is an advantage if you have been working with Notified Bodies, FDA, or other regulatory authorities
• Excellent proficiency in English and Finnish is required, (both spoken and written)
• Self-driven, proactive, and analytical way of working
• Effective communication and interpersonal skills
• Occasional flexibility with working hours to meet different time zone requirements

What we offer:

• The opportunity to work in a growing company that makes a real difference - Blueprint Genetics has a clear and motivating purpose to improve the lives of patients and families affected by inherited diseases.
• Excellent timing for joining the next chapter of a unique company. Blueprint Genetics was acquired in 2020 by Quest Diagnostics, the world's leading provider of diagnostic information service. Now is the time to bring best-in-class genetic testing to the global market at scale.
• Hybrid work - we like to see each other in the office every now and then but offer the opportunity to work remotely as well.
• A friendly, flexible and multicultural work environment with great people from different fields of expertise. We are a team of experienced professionals, who collaborate to drive genetic knowledge forward.
• Flexible working conditions and employee benefits such as participation in performance-based bonus payment system, extensive occupational healthcare with Heltti, sports, culture & wellbeing benefit, lunch benefit, team events & office parties.

How to apply
If you are interested in hearing more, please send us your application and CV at the latest on Monday, September 23. Interviews will be started during the application period and the position will be filled as soon as a suitable candidate is found. We hope to hear from you soon!
Who we are:
Blueprint Genetics is a Quest Diagnostics company. Quest Diagnostics, A Fortune 500 company, is the world's leading provider of diagnostic information services. www.questdiagnostics.com

Espoo

Vakituinen, Hybridityö

20 000 000 - 49 999 999 €

250 - 499 henkilöä