Regulatory Affairs Specialist

1 day ago


New Bedford, Massachusetts, United States Werfen Full time
Job Summary

The Principal Regulatory Specialist is responsible for ensuring compliance with regulatory requirements for SaMD products in domestic and international markets. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO 13485 and other international standards.

Key Responsibilities
  • Develop and execute regulatory strategies and plans throughout the lifecycle of SaMD products.
  • Collaborate with cross-functional partners to implement changes in the Quality Management System to support regulatory compliance.
  • Assess software safety classification and prepare regulatory plans assessing worldwide country registration requirements.
  • Act as the liaison and point of contact for all interactions and communications with Regulatory Agencies and Notified Bodies.
  • Author and support regulatory filings for market clearance, licensing, registration, and legalization.
  • Support the development and maintenance of Technical Files, Design Dossiers, Design History Files, and Product Files.
  • Provide regulatory guidance to Product Development Teams during New Product Development and change implementation.
  • Assess product modifications for regulatory impact and prepare needed submissions.
  • Review and approve labeling and other product marketing promotional materials related to new products and significant changes.
  • Support product-related third-party audits.
  • Author post-market surveillance reports.
  • Support changes to regulatory procedures in alignment with evolving technologies, regulations, and standards.
Requirements
  • Bachelor's degree or higher in Science, Engineering, and Regulatory.
  • Minimum of 10 years' experience in regulatory approval processes for medical devices or in vitro diagnostics, with at least 5 years related to software as a medical device (SaMD).
  • Advanced knowledge of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO 13485 and other international standards.
  • Experience working with Artificial Intelligence Product submissions desirable.
  • Regulatory Affairs Certification (RAC) desirable.
  • Ability to thrive in a fast-paced, technical, and mission-focused Agile organization.
Werfen is an Equal Opportunity Employer

Werfen strictly prohibits unlawful discrimination, harassment, or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.



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