Regulatory Manager

Role Description

The position is primarily based at Bonalive’s Turku headquarters. During the onboarding phase, work is carried out on-site. After that, hybrid work is possible (remotely up to 2 days per week). The preferred start date is as soon as possible, ideally by August 10, 2026.

Key responsibilities:

• Responsible for US regulatory projects and submissions
• Coordinate product registrations in close collaboration with our distributors globally
• Coordinate cross-functional labeling team in order to prepare product labeling materials, labeling verifications, and translations, as necessary
• Oversee regulatory communications with marketing to ensure appropriate approval of commercial literature and language.
• Identify and interpret regulatory requirements and keep other teams informed
• Responsible for product databases (e.g. GUDID, EUDAMED)
• Maintain technical documentation compliance
• Create and maintain written instructions in your area of expertise
• Act as an internal auditor

Technical requirements for the role:

• BSc. or MSc. degree (medicine, pharmacy, biosciences or another relevant scientific discipline)
• 5+ years’ experience within a relevant field
• Knowledge of MDR/IVD, FDA, ISO 13485
• Good written and spoken skills in English and Finnish
• Good MS Office skills
• Experience in project management
• Experience in conducting internal audits is considered an advantage

We are looking for more than technical competence — we are looking for the right person.

In this role, success comes from a combination of regulatory expertise, ownership, and strong collaboration skills. You are structured and detail-oriented, but you also understand the bigger picture and business impact behind regulatory decisions. You are comfortable working with internal stakeholders, external partners, and authorities, and you know how to communicate clearly and professionally in demanding situations.

As a person, you care about doing things well, supporting others and helping the organization succeed. You bring positive energy and emotional judgement to the team. You are willing to challenge when needed, but always constructively and respectfully.

At Bonalive, our values are Daring to Challenge and Genuine Caring, and we are looking for someone who naturally lives both.

We offer you a meaningful role in a growing medical device company, where your work directly supports patient safety and product availability. We have a unique small company atmosphere with an ownership mindset that allows you to make close-to-the-customer decisions. Welcome to our team!

The position will be filled as soon as a suitable applicant is found. For further information about the position, send an email to Quality Director Marika Ojala, marika.ojala@bonalive.com or call +358 44 5866798 on May 12th at 13:00–14:00 or May 13th at 09:00–10:00.

If you are interested, please send your application and CV to recruitment@bonalive.com by 23.05.2026 at the latest. We go through applications as they come, so do not hesitate to send your application today.

 

 

Links:

 

Regulatory Manager – Bonalive Oy – Työpaikat – Duunitori

Regulatory Manager | Bonalive | LinkedIn