Job Description

Job Advertisement: Regulatory Affairs Manager

Location: Boston, MA (3 days a week in the office)

Company: Confidential (Stealth-mode startup environment)

Salary: $150,000 - $180,000 (including equity)

About Us: We are a dynamic startup focused on developing innovative diagnostic tools for healthcare. Our mission is to leverage advanced technology to provide non-invasive, dignified, and actionable diagnostic solutions for healthcare.

Position Overview: We are seeking a hands-on Regulatory Affairs Manager with a strong background in medical devices, particularly SaMD (Software as a Medical Device). This role is crucial for ensuring our products meet all regulatory requirements and standards. You will be responsible for managing regulatory submissions, maintaining compliance, and supporting the growth of our regulatory team.

Key Responsibilities:

• Create and maintain 510(k) and De Novo submissions.
• Manage ISO and FDA audits.
• Prepare and update documentation for EU MDR conformity.
• Collect, appraise, and analyze clinical data for medical devices.
• Write and maintain Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports.
• Collaborate with internal and external stakeholders to ensure comprehensive analysis and dissemination of clinical evidence.

Qualifications:

• 4+ years of experience in Regulatory Affairs, specifically with medical devices and SaMD.
• Experience with FDA submissions and writing MDR-compliant CERs and PMCFs.
• Familiarity with FDA 21 CFR Parts 801, 803, 807, 812, 820; ISO 13485:2016, MDD/MDR CE Marking.
• Strong documentation skills and a hands-on approach.
• Experience in a startup or smaller company environment preferred.
• Ability to relocate if necessary, with a clear understanding of the job requirements.

Compensation:

• Competitive salary at $140,000 - $200,000 (including equity and annual bonuses based on performance).

How to Apply: Please submit your resume and a cover letter detailing your relevant experience and why you are a good fit for this role. We are looking for candidates with stable career histories and a passion for innovation in the medical device industry.

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