Senior Regulatory Affairs Specialist

Scorpion Therapeutics; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for medical devices and in vitro diagnostics across domestic and international markets. You will develop strategies for FDA submissions (510(k), PMA, IDE) and ex-U.S.

filings, interpret global regulations, and guide cross-functional teams. Responsibilities include preparing documentation, monitoring clinical study status, reviewing labels and promotional materials, and responding to agency

Qualifications

• Bachelor's degree in biological sciences or related field.
• Minimum 5 years of device, diagnostic, or pharma regulatory affairs.
• Strong knowledge of U.S., EU, and global regulatory requirements.
• Experience with GLP, QSR, and quality systems.

Responsibilities

• Develop and execute strategies for FDA submissions (510(k), PMA, IDE) and ex-U.S. submissions.
• Interpret global regulations and guide product development teams.
• Prepare regulatory documentation and monitor clinical study status.
• Review labels and promotional materials; respond to agency requests.

Skills

Regulatory affairs

FDA submissions

Global regulatory knowledge

Quality systems (GLP/QSR)

Education

Bachelor's degree in biological sciences

Job description

Role: Senior Regulatory Affairs Specialist for medical devices and in vitro diagnostics, focusing on regulatory submissions and compliance across domestic and international markets.

Responsibilities: develop and execute strategies for FDA (510(k), PMA, IDE) and ex-U.S. submissions, interpret global regulations (U.S. and EU), guide product development teams, prepare documentation, monitor clinical study status, review labels and promotional materials, and respond to agency requests.

Qualifications: Bachelor's in biological sciences or related field, minimum 5 years in device, diagnostic, or pharma regulatory affairs; strong knowledge of U.S., EU, and global regulatory requirements; experience with GLP, QSR, and quality systems.

High-Value: expertise in medical device and IVD regulation, clinical study review, regulatory strategy, and international registration; remote work in the USA; no travel specified.