- 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 meet regulatory requirements,
- Develop North America regulatory strategies plan for submission for IVD products
- Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate 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 of IVD 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 promotional materials 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:
- Bachelors Degree in a life science related field
- 8-10+ years of experience in a regulatory role supporting 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