The Regulatory Specialist III performs product registrations and act as the company representative with the applicable regulatory authorities. The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Regulatory Specialist III reviews labeling and marketing materials for regulatory compliance. Additionally, the position supports Quality System compliance by reviewing design documents and implementing compliance mechanisms for new and emerging regulations, standards, and regulatory guidance. The Regulatory Specialist III ensures information and data in support of marketing authorizations is complete and accurate. This position collaborates with personnel with the business unit and company.
- Design Control: Assess marketing authorization requirements for design control projects. Identify and assess regulatory risks then provide regulatory strategy to functional and project teams for market authorization in indicated geographies. Review supporting documentation for acceptability of data, procedures, and other documentation to ensure clear, accurate representation of product. Confirm conclusions are supported by data and their associated risk assessments. Provide regulatory support to project core teams.
- Marketing Authorizations: Assess and document assessment of regulatory marketing requirements for global markets. Schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals according to governing rules governing rules and regulations of the affected geographies. Perform or ensure activities to obtain global market authorization in domestic and international geographies including submissions, registrations, apostilles, declarations, license applications, attestations, certifications, design dossiers, and technical documentation, export certificates, and device listings. Maintain product technical documentation and ongoing activities related to compliance with global regulatory directives and regulations. Create records in central repository of market authorization deliverables and responses. Represent company in interactions and communications with regulatory authorities to obtain timely market authorizations. Coordinate with internal personnel to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Regulatory Intelligence: Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies. Monitor and analyze the development of new and emerging regulations, guidance, and standards in marketed geographies. Coordinate evaluation of new and emerging standards with Subject Matter Experts. Assist in the development of plans for meeting and complying with new regulations, guidance, and standards. Assist in developing strategy for complying with new and emerging regulations, guidance, and standards. Regulatory Strategic and Tactical Management. Assist Regulatory management with development of strategic and tactical options. Implement regulatory strategies and tactics to accomplish company goals and initiatives. Manage regulatory consultants.
- Quality Management System Support: Assist in the education and broadening the regulatory knowledge within the Accelerate teams. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Regulatory processes. Support Regulatory function and assist other departments in audit and inspection preparation. Provide back-up support for Regulatory Team.
- Perform other duties as directed.
Minimum Knowledge & Experience required for the position:
- Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.
- Regulatory Affairs Certification preferred
- Ten (10) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which five (7) should be Regulatory.
- Experience in regulatory submissions including 510(k) and notified body technical documentationrequired
- Experience in international registrations required.
- Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
- Advanced knowledge knowledge of regulatory intelligence tools and methods along with ability to interpret and apply regulations.Working knowledge of electronic publishing/file management system
- Advanced skills in verbal and written communication including proofreading, scientific writing, presenting presusive arguments in a positive tone, and presentation to various organizational levels.
- 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 proactive and creative approaches to problem-solving including creating regulatory strategies that balance short and long-term objectives while adhering to timelines.
- Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.