Job Summary

The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System  for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies and plans throughout the lifecycle of the SaMD products.

This role acts as a subject matter expert that helps to ensure compliance with applicable international regulations in which the company does business; preparing product regulation plans and submission documentation for international markets and evaluating product changes for effects on regulatory license registrations.

Key Accountabilities (Digital Factory Products)

• Conceive of and Implement the Regulatory Strategy in collaboration with Cross-Functional (Solution Leaders, SBU Marketing, Medical Affairs, BU Regulatory and other) partners.
• Collaborate with Digital Solutions QA to implement changes in the Quality Management System to support the Regulatory Strategy.
• Assess Software Safety Classification.
• Prepare regulatory plans assessing worldwide country registration requirements.
• Act as the liaison and point of contact for all Digital Factory 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, prepare needed submissions and review and approve related change orders.
• 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.

Networking/Key Relationships

• SBU Marketing
• Medical Affairs
• BU R&D
• BU Regulatory
• Solution Leaders
• Digital Solutions QA
• Legal
• Other Werfen departments as needed

Minimum Knowledge & Experience required for the position:

• Education: Bachelor’s degree or higher, in Science, Engineering, and Regulatory.
• Experience: 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).

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

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.
• Works closely with other functions to generate Regulatory documents in alignment with quality procedures related to applicable Regulatory requirements, standards, regulations, and best practices.
• Able to effectively communicate Regulatory requirements to a broad population of constituents.
• Ability to negotiate and influence others in establishing direction toward improved and enhanced Regulatory compliance.
• Must possess extensive knowledge of Regulatory Affairs as it applies to the product life cycle as well as other related processes gained from work experience.
• Ability to maintain responsibility for process or key area of Regulatory
• Expert level of understanding of Regulatory requirements
• Strong writing, editing and analytical skills and have experience in developing complex submissions with minimal supervision.
• Ability to evaluate Regulatory impact of proposed product and / or process changes

Travel Requirements:

• Approximately ≤10% of time