Regulatory Manager
About this role
Bonalive Oy
As the world seeks answers to the growing threat of antibiotic resistance, Bonalive represents a new standard in patient care. Evolving at the intersection of technology and human biology, our Smart Healing™ technologies reduce antibiotic treatments and enable a better quality of life for patients. Smart Healing™ encompasses our commitment to our customers. It defines everything we do, in providing patients and surgeons well-proven and safe bone regenerative products in orthopedics, trauma, spine, septic bone and ear surgery. Bonalive is a smart biomaterials company transforming the future of healthcare. With one of the most evidence-based technologies in the industry, we are creating a smarter future for healthcare. Bonalive is an ISO 13485:2016 certified, Class III medical device company, headquartered in Turku, Finland. www.bonalive.com
Role Description
We are seeking an experienced Regulatory Affairs Manager to ensure continuity of regulatory activities, with strong technical expertise in ISO 13485 and FDA quality systems.
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.
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 ex