top of page
About the Role
You will develop comprehensive regulatory plans, including budgets, timelines, and resource allocations, to obtain product approvals in new markets.
Build evidence to support the Substantial Equivalence of TECHFIT’s products with similar products on the market.
Write test protocols and reports for product and process validations.
Communicate with regulatory bodies and consultants.
Prepare and submit regulatory filings.
Implement action plans that ensure the closing of regulatory gaps.
Requirements
US Visa.
English – B2.
Professional in Biomedical Engineering or related careers.
Desired: experience with regulatory submissions.
Desired: ISO 13485/21 CFR 820 knowledge.
bottom of page