Regulatory Affairs Manager Job at Stark Pharma Solutions Inc, Pennsylvania

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  • Stark Pharma Solutions Inc
  • Pennsylvania

Job Description

Position: Regulatory Affairs Manager

Location: Philadelphia, PA (Remote must be within Eastern Time Zone)
Experience: 10+ years
Industry: Medical Device

About the Role

We're looking for a Regulatory Affairs Manager 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.).

Job Tags

Remote work,

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