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Regulatory Compliance Manager I
2 months ago
Overview:
As a Regulatory Compliance Manager I at Werfen, you will play a pivotal role in overseeing the pre-market regulatory activities essential for ensuring adherence to various global standards, including US FDA, Health Canada, and European regulations for in vitro diagnostic devices.
Key Responsibilities:
Pre-Market Activities:
Engage with design teams to represent regulatory interests, develop regulatory strategies, and prepare submissions for US FDA 510(k) and Health Canada, along with necessary EU technical documentation.
Review product labeling and marketing materials to ensure compliance with regulatory standards, including brochures, presentations, and training documents.
Collaborate with design teams on new product developments and significant modifications, providing early insights on testing requirements, acceptance criteria, and regulatory submission strategies.
Advise on product classifications and registration pathways in key markets such as Australia, Brazil, Canada, Japan, and the United States.
Conduct thorough reviews of product labeling and change orders for new and modified products.Prepare and submit FDA 510(k) and Health Canada license applications for new products and significant changes, coordinating with R&D and Marketing teams. Author analytical and clinical reports as required and liaise with regulatory agencies to provide guidance on registration strategies and requirements.
Develop EU technical documentation for new products and significant modifications, ensuring collaboration with R&D and Marketing, and authoring relevant sections of analytical and clinical reports. Interface with notified bodies as necessary during the registration process.
Review commercial materials, including brochures, presentations, and training resources, to ensure regulatory compliance with registrations.
Address additional regulatory needs to comply with global standards.
This role offers a hybrid work environment, requiring three days per week in the office and two days from a remote location within commuting distance.
Qualifications:
Minimum Requirements:
A Master's degree in Regulatory Affairs or a related field, accompanied by two years of managerial experience in the medical device or IVD sector.
Alternative Requirements:
A Bachelor's degree in Regulatory Affairs or a related field, along with five years of managerial experience in the medical device or IVD sector.
Essential Skills:
(I) Experience in (a) preparing and submitting regulatory 510(k)s for medical devices or IVD products within the last eight years; (b) utilizing ERP and PLM software, such as SAP; and (c) representing the regulatory department during external audits by regulatory bodies; (II) Comprehensive knowledge of (a) FDA, EU regulations, and Health Canada guidelines; (b) principles for developing global regulatory strategies; (III) Familiarity with EU MDR, IVDR, MDSAP Companion Document, ISO 13485, and ISO 14971; (IV) Strong verbal and written communication skills in both individual and group settings; (V) Attention to detail with excellent organizational abilities and a proven track record of meeting deadlines; (VI) Capacity to manage multiple projects with effective planning and prioritization; and (VII) Demonstrated leadership capabilities at the direct report level and in cross-functional collaborations.
