Clinical Affairs Specialist (Medtech)

TL;DR

Clinical Affairs Specialist (Medtech): Developing and executing clinical affairs strategies to support radiation therapy software with an accent on regulatory submissions, clinical evaluations, and compliance. Focus on ensuring market access and maintaining quality standards for innovative cancer treatment automation tools.

Location: Remote (US)

Salary: $120,000–$190,000 USD

Company

hirify.global creates automated software solutions to detect medical errors and save time for clinicians in the field of radiation therapy.

What you will do

• Assist in the preparation of regulatory submissions and impact assessments.
• Perform clinical evaluation plans and reports to ensure product compliance.
• Conduct literature searches and reviews to identify state-of-the-art procedures.
• Collaborate with regulatory agencies and partners worldwide for market access.
• Maintain compliance with quality management systems and ISO 13485.
• Update annual post-market surveillance and clinical evaluation reports.

Requirements

• 3+ years of Radiation Oncology clinic experience as a medical physicist, medical physics assistant, or dosimetrist.
• Ability to research journals and write technical reports for independent review.
• Experience with test protocols and clinical evaluations.
• Strong analytical skills and ability to meet strict regulatory deadlines.
• Must be eligible to work in the US or reside in a location supported by our global EOR partners.

Nice to have

• 3+ years of clinical affairs experience performing clinical evaluation reports.
• Experience with EU-MDR submissions, including writing CEPs and CERs.
• Familiarity with the PRISMA model.

Culture & Benefits

• Competitive salary with immediate health, vision, and dental insurance.
• 401(k) with immediate employer match.
• Self-managed PTO and 10 paid holidays.
• Monthly internet stipend and home office setup support.
• Fully remote work environment with yearly retreats.