Regulatory Affairs Specialist
3 weeks ago
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 strong 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, ensuring compliance with applicable regulations and standards.
- Collaborate with cross-functional teams to prepare regulatory plans and submission documentation for international markets.
- 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, 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.
- 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.
- 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.
Approximately ≤10% of time.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
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