- 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.
- SBU Marketing
- Medical Affairs
- BU R&D
- BU Regulatory
- Solution Leaders
- Digital Solutions QA
- Legal
- Other Werfen departments as needed
- 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).
- 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
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Principal Regulatory Affairs Specialist - Bedford, United States - Werfen
Description
Overview
Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
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.
Responsibilities
Key Accountabilities (Digital Factory Products)
Networking/Key Relationships
Qualifications
Minimum Knowledge & Experience required for the position:
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
Travel Requirements:
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. 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. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
