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Senior Regulatory Affairs Specialist: SaMD & MedTech

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: OrganOx
Full Time position
Listed on 2026-10-07
Job specializations:
  • Healthcare
    Medical Science Liaison, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 120000 - 160000 USD Yearly USD 120000.00 160000.00 YEAR
Job Description & How to Apply Below

Organ Ox is seeking a Senior Regulatory Affairs Specialist to prepare regulatory submissions (FDA Q-Submissions, INDs, IDEs and PMAs) for North America, and to assist in implementing the company’s quality goals and objectives.

The role reports to the Director, Regulatory Affairs, Software and Innovation, and collaborates with cross-functional teams. It may require up to 5% travel domestically or internationally, with a flexible remote or hybrid on-site work arrangement.

We are looking to fill the Senior Regulatory Affairs Specialist:
SaMD & Med Tech position at Organ Ox in Boston, MA, United States.

The advertised compensation is 120..

We aim to respond to suitable candidates as soon as possible.

Full responsibilities and requirements are described in the listing above.

Learn more about the Senior Regulatory Affairs Specialist:
SaMD & Med Tech role in the description above.

Position Requirements
10+ Years work experience
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