Job Title: Regulatory Affairs Specialist I-III
Location: San Diego, CA (Hybrid)
Austin Vita is delighted to support a worldwide diagnostic company based in San Diego, who is looking for a Regulatory Affairs specialist to join a growing team.
The Regulatory Affairs Specialist performs product registrations and acts as the company representative with the applicable regulatory authorities. The position researches regulatory requirements and provides recommendations for options for regulatory submissions, approval pathways and compliance activities. The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations.
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. Assemble and 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, research, 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 (SMEs). 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 through the development of regulatory plans to support product improvements and new product introductions. 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 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.
As needed, provide assessment of new external standards and applicability to Werfen AID.
As needed, cross-trains peers on AID systems and processes.
Comply with all applicable standard operating procedures (SOPs), QSR regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
Perform other duties as directed.
Minimum Knowledge & Experience:
Bachelor's degree in a life science, engineering, or equivalent required. Advanced degree preferred.
Regulatory Affairs Certification preferred.
Work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which two (2) should be Regulatory.
Experience in regulatory submissions including 510(k) and notified body technical documentation required.
Experience in international registrations.
Project management experience preferred.
Skills & Capabilities
Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
Working 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 persuasive arguments in a positive tone, and presentation to various organizational levels.
Working 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.
Working 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.
Working ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
Limited Travel Required