Director Regulatory Affairs

The Regulatory Affairs Director will build and lead a growing Regulatory Affairs team by recruiting, managing, coaching, and developing the team to ensure skills are aligned with a high-performing organization. This position will direct the Regulatory team in supporting products over their lifecycle from new product development, market authorization documentation, labeling review, design changes, post-market activities including field actions, reportable events, and surveillance. The Director will confirm information and data in support of marketing authorizations, regulatory reports, and post-market documentation is complete and accurate to state-of-the-art guidances, standards, and regulations.

Responsibilities:

• Guide cross-functional teams in defining regulatory requirements, identifying regulatory risks then generating, deploying, and implementing corresponding regulatory strategies.
• Confirm the appropriateness of internal evidence of safety and efficacy for acceptability in licensing applications, submissions, and registrations for market authorization in indicated geographies.
• Provide guidance with input from regulatory bodies and distributing partners on the most effective regulatory path for achieving marketing authorization.
• Lead team to schedule milestones, generate supporting documentation and provide deliverables for assigned global regulatory applications, registration, licensing, reporting. submissions declarations, attestations, certifications, design dossiers, technical documentation, export certificates, and renewals according to governing rules and regulations of the affected geographies.
• Oversee the final review of market applications to ensure compliance with regulatory agency standards and requirements for submissions.
• Represent the company in interactions and communications with regulatory authorities.
• Coordinate with internal personnel to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies.
• Manage team in creation, changes to, review, assessment and maintenance of design changes, product labeling, advertising and promotional materials, design dossiers, technical documentation, regulatory agencies communications, post-market reports, health hazard evaluation, risk-benefit reports, reportable event assessments and filings, and Field Action/FSCA assessments and filings, license application and renewals, and laser reports while ensuring records organized maintained in central repository.
• Represent company in interactions and communications with regulatory authorities.
• Actively participate in trade and professional organizations to maintain current knowledge of applicable regulatory requirements and scientific breakthroughs in the marketed geographies and technologies.
• Monitor, analyze and develop strategies for new and emerging regulations, guidances, and standards in marketed geographies.
• Deploy and coordinate plans for establishing and maintaining compliance. Communicate impact on the business or portfolio to senior management.
• Educate and broaden the regulatory knowledge of the department and understanding of other functions.
• Implement regulatory projects to accomplish company goals and initiatives.
• Recruit, develop, and maintain highly qualified staff, foster staff career development, and provide technical guidance.
• Mentor, train, set expectations, ensure accountability, and perform evaluations for the Regulatory team.
• Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities.
• Support regulatory inspections and third-party audits. Provide back-up support for Regulatory Team.
• Supervisory and administrative duties such as PTO management. Educates and manages assigned area to ensure compliance with applicable Standard Operating Procedures (SOPs), ISO, FDA, and other applicable Quality Systems regulations, as well as Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Represents the Management team and reflects the company's values as a role model to employees and customers.

Background Requirements:
· Bachelor's degree in life science, engineering, or equivalent required.
· Advanced degree preferred.
· Regulatory Affairs Certification preferred.
· 10-15+ years of work experience in in vitro diagnostic or medical device industry including managing regulatory professional teams.
· Demonstrated record of accomplishment in obtaining successful marketing authorizations in US and ex-US required.
· Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
· Advanced ability to mentor, train, and develop skills of staff in regulatory concepts and their implications.
· Advanced knowledge of regulatory intelligence tools and methods along with ability to interpret and apply regulations.
· Advanced skills in verbal and written communication including scientific writing and presentation.
· Advanced skills in leadership, influence, and negotiation with the ability to build collaborative relationships.
· Advanced ability to organize and complete multiple assignments in a fast-paced environment in a timely, accurate manner as a team member and/or as an individual contributor.
· Advanced ability to develop regulatory strategies that balance short and long-term objectives while adhering to timelines.
· Advanced ability to function effectively with ambiguity in a rapidly changing environment while developing proactive and creative approaches to problem-solving.
· Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
· Advanced knowledge and ability to optimize use of electronic tools such as e-publishing, salability control databases, and e-file management system