• Oversee North America Regulatory activities
• Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs
• Ensure participation on cross functional project teams to provide strategic and tactical guidance to meetregulatory requirements,
• Develop North America regulatory strategies plan for submission for IVD products
• Assess changes to product, manufacturing processes, labeling affecting IVD products andcommunicate to global Regulatory and project teams for impact assessment
• Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products
• Maintain up-to-date knowledge ofIVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business
• Provide input and feedback on clinical study protocols to ensure regulatory requirements are incorporated
• Support CE marking activities for IVD products and other market clearance for products manufactured globally
• Review and approve promotionalmaterials and product labeling
• Support importation/exportation permitting activities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Basic Qualifications:

• Bachelor's Degree in a STEM field
• 12+ years of experience in a regulatory rolesupporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)

OR

• Master's or PhD degree in a STEM field
• 10+ years of experience in a regulatory rolesupporting the Americas region and international registrations (US 510(k), PMA, DE NoVo submissions)

Preferred Qualifications:

• Travel as circumstances dictate
• Excellent understanding of regulations and guidance documents required in Americas region
• RAC certified
• Excellent interpersonal, verbal and written communication skills (in English)
• Excellent time management, organizational, negotiation, and problem-solving skills
• Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and levels of management