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Regulatory Compliance Expert

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.

Key Responsibilities

  • Develop and implement regulatory strategies for domestic and international markets.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Assess software safety classification and prepare regulatory plans for worldwide country registration requirements.
  • Act as liaison and point of contact for 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.
  • Support product-related third-party audits.
  • Author post-market surveillance reports.

Requirements

  • Bachelor's degree or higher in science, engineering, or 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 and other international standards.
  • Regulatory Affairs Certification (RAC) desirable.
  • Ability to thrive in a fast-paced, technical, and mission-focused Agile organization.
  • Strong writing, editing, and analytical skills, with experience in developing complex submissions.
  • Ability to evaluate regulatory impact of proposed product and/or process changes.

Travel Requirements

  • Approximately ≤10% of time.

About Werfen

Werfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions. Our company values diversity and is an Equal Opportunity/Affirmative Action Employer M/F/D/V.