Kuvaus
Type: Full-time, permanent
Location: Otakaari 5, 02150 Espoo, Finland
Application DL: 2.3.2025
Do you want to contribute to meaningful work and help improve patient safety in operating rooms? Surgify Medical, a medical technology company specializing in surgical innovations, is looking for a Regulatory Affairs Specialist to join their team.
Key responsibilities
As a Regulatory Affairs Specialist, you will be responsible for regulatory submissions and compliance processes, ensuring that Surgify Medicals technology meets global regulatory standards. Your main responsibilities will include regulatory filings, documentation, and interactions with authorities such as Fimea and the FDA.
You will oversee registrations across multiple markets, ensuring compliance with international medical device regulations. Additionally, you will support clinical documentation processes and collaborate closely with internal teams, including sales and engineering, to align regulatory strategies with business goals.
What makes you a great fit?
We are looking for a person with a solid understanding of regulatory processes and medical device compliance. You have previous experience in regulatory affairs and thrive in a fast-paced startup environment. You enjoy taking ownership, are eager to grow your role within the company, and have strong attention to detail with the ability to work with precise regulatory requirements.
We hope you have:
– Relevant higher education degree
– A couple of years of relevant work experience in regulatory affairs
– Knowledge of regulatory processes, such as EU MDR and FDA 510(k) submissions
– Full working proficiency in English
We consider as an asset:
– Familiarity with clinical documentation processes
Surgify Medical offers you:
– The opportunity to work at the forefront of medical innovation and make a tangible impact on patient safety. – Learn more about Surgify Medicals products here.
– A chance to grow professionally and take on more responsibility as the company expands
– A dynamic and international work environment with a collaborative team
– Flexible hybrid work options and a supportive company culture
Practicalities:
In this full-time and permanent position, you will be employed directly by Surgify Medical. The start time in the role is as soon as possible. The role will be located in Espoo, and we hope you are able to work at the office weekly as part of a hybrid model.
Does this sound like the next step in your career? Please submit your CV and motivation letter in PDF-format by the latest 2nd of March via our application system here: https://emp.jobylon.com/applications/jobs/275708/create/ . Please also mention your salary request and the earliest possible starting date in your application documents. We are actively reviewing applications throughout the application period and processing them in the order they are received. Remember to use the application system, we do not accept applications by email.
You can familiarize yourself with Surgify Medical here: https://www.surgifymedical.com/. For more information about the position and the recruitment process please contact aTalents Recruitment Consultant Säde Juntunen (+358 44 901 2283, sade.juntunen[at]atalent.fi).
Company description
Surgify Medical is a Finnish health technology company dedicated to developing safer surgical solutions. Its flagship product is a unique drill bit technology designed to protect soft tissues and nerves during surgery, reducing the risk of complications. Surgify’s innovative solutions are tailored to the needs of neurosurgery, orthopedics, and ear, nose, and throat (ENT) surgery. The company’s mission is to enhance surgical safety and efficiency for both patients and healthcare professionals.
Lähde: Työmarkkinatorin asiakastietojärjestelmä
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