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Regulatory Affairs Specialist

2 months ago

Bedford, Bedford, United Kingdom Werfen Full time
Job Summary

The Principal Regulatory Specialist is a key member of the Werfen team, responsible for ensuring compliance with regulatory requirements for medical devices and in vitro diagnostics. This role requires a deep understanding of FDA, MDSAP, IVDR, MDR, and international regulations, as well as ISO and other international standards.

Responsibilities
  • Develop and implement regulatory strategies for SaMD products, collaborating with cross-functional teams to ensure compliance with quality management systems.
  • Assess software safety classification and prepare regulatory plans for worldwide country registration requirements.
  • Act as the liaison and point of contact for regulatory agencies and notified bodies, authoring and supporting regulatory filings for market clearance, licensing, registration, and legalization.
  • Provide regulatory guidance to product development teams during new product development and change implementation, assessing product modifications for regulatory impact and preparing needed submissions.
  • Review and approve labeling and other product marketing promotional materials related to new products and significant changes, supporting product-related third-party audits and authoring post-market surveillance reports.
Qualifications
  • Bachelor's degree or higher in Science, Engineering, and Regulatory, with a minimum of 10 years' experience in regulatory approval processes for medical devices or in vitro diagnostics, and 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 and other international standards, with experience working with Artificial Intelligence product submissions desirable.
  • Regulatory Affairs Certification (RAC) desirable, with the ability to thrive in a fast-paced, technical, and mission-focused Agile organization.
About Werfen

Werfen is a worldwide developer, manufacturer, and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. Our success comes from a specific focus in rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.