Principal Regulatory Affairs Engineer

Position : Principal Regulatory Affairs Engineer

Location : Philadelphia, PA (Remote must be within Eastern Time Zone)

Experience : 10+ years

Industry : Medical Device

About the Role

We're looking for a Principal Regulatory Affairs Engineer with a strong background in medical devices and deep experience in 510(k) submissions for Software as a Medical Device (SaMD) products. This role is ideal for someone who's well-versed in navigating the FDA regulatory landscape, can lead submissions from start to finish, and collaborate closely with cross-functional teams to ensure full regulatory compliance throughout the product lifecycle.

Key Responsibilities

Lead and prepare regulatory submissions including 510(k) , Technical Files , and Design Dossiers for SaMD and medical device products.

Develop and execute regulatory strategies to support product development, registration, and post-market activities.

Interpret and apply global regulatory requirements (FDA, EU MDR, ISO 13485, IEC 62304) for SaMD.

Review design and development documentation to ensure compliance with applicable regulations and standards.

Communicate effectively with regulatory authorities and manage submission timelines and responses to inquiries.

Partner with R&D, Quality, and Clinical teams to ensure product documentation meets regulatory standards.

Monitor changes in relevant regulations and standards, assessing impact on existing and future products.

Support internal audits, inspections, and risk management activities related to regulatory compliance.

Required Qualifications

Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline. (Master's preferred)

10+ years of experience in regulatory affairs within the medical device industry.

Proven track record of authoring and submitting successful 510(k) submissions for SaMD products.

Strong understanding of FDA , ISO 13485 , IEC 62304 , ISO 14971 , and EU MDR regulatory frameworks.

Experience working cross-functionally with engineering, clinical, and quality teams.

Excellent documentation, communication, and project management skills.

Preferred Skills

Regulatory Affairs Certification (RAC) or equivalent credential.

Experience with software lifecycle documentation and cybersecurity requirements for SaMD.

Knowledge of AI / ML-based SaMD regulatory considerations.

Familiarity with international submissions (Health Canada, EU, etc.).