US Regulatory Lead - Bioretec Oy - Remote - Global
Regulatory Lead
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Job Description
Bioretec is expanding in the US and seeks an experienced regulatory professional to lead FDA strategy, manage filings, and collaborate globally. The role involves preparing submissions like 510(k), IDE, and De Novo, acting as the primary FDA contact, and advising on clinical study design. Requirements include 10+ years in medical device regulation, successful FDA submission record, and near-native English. The position offers strategic influence, collaboration with US and EU partners, and flexible remote work within the EU or UK.
Company Information
| Location | Active listings |
|---|---|
| Tampere, Finland | 3 |
| Remote - Global | 1 |
| Role type | Active listings |
|---|---|
| Human Resources Specialist | 1 |
| Engineer | 1 |
| Taloushallinnon tuntityöntekijä | 1 |
| Open application | 1 |
| Role level | Active listings |
|---|---|
| Mid-Level | 2 |
Bioretec Oy appears in 4 indexed job postings in JobCrawls' Finland dataset since May 2025. In that historical index, the strongest location signals for this employer are Tampere, Finland and Remote - Global.
About
Includes details from the Finnish Trade Register.
Osakeyhtiö
Manufacture of medical and dental instruments and supplies (excl. dentures)
Financial Overview (2024)
Bioretec Oy was unprofitable in 2024 with revenue of €4.5M and a profit margin of -0.9%.
Data shown is based on historical job postings from our database.
Job Details
Education Level
None requiredBenefits & Perks
Recruitment Process
- 1Application review ongoing
- 2Interview process
