Overall responsibility for strategically planning and directing a team managing US regulatory submission strategies.

Essential Duties and Responsibilities

• Hire, manage and develop a team to support all Regulatory Affairs activities, including their growth, development and retention.
• Creates functional strategies, goals, budgets and objectives for department.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Oversee the planning and execution of regulatory filings and responses to FDA..
• Provides guidance on all government and regulatory agency submissions.
• Ensures compliance with ISO standards and regulations.
• Identifies and advises headquarters of risks, concerns, early on in the process and works to find solutions.
• Remains current with FDA regulation knowledge, ISO standards, as well as other government regulations for the US.
• Develops successful relationships with all regulatory authorities, using the ability to lobby, especially with the FDA.
• Maintain records regarding regulatory submissions
• Guide team in studying scientific and legal documents

Education and Requirements

• Bachelor’s Degree from a four year college or university required. Advanced degree in related field preferred.
• Seven to ten years direct related experience and five years management experience required.
• Must have direct prior experience as a key interface with FDA , in IVD, with extensive knowledge in FDA requirements. Hematology, hemostasis a plus, along with a successful track record in FDA submissions and approvals.
• Must have recent direct experience with registration of instrumentation, and ideally reagents.

Skills

• Excellent computer skills, including a good working knowledge of software related to instrumentation.
• Excellent communication skills are required, both written and verbal, including presentation skills. Prior lobbying experience with FDA is a plus. Candidate should have the ability to work with complex teams for a foreign company, with cultural differences. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to see market opportunity and balance compliance; quality, safety and the appropriate regulatory strategy to gain market approval while considering speed to market and costs.
• Ability to deal with RA technical issues on a daily basis.
• Ability to interpret RA rules and guidelines as a contribution to business development while maintaining compliance.
• Up to 40% travel, international travel required.

 Ideal candidates will be located within a commutable distance to our Parsippany, NJ office.

This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as determined by customer requirements.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.