What are the responsibilities and job description for the Staff Regulatory Affairs Specialist position at BioTalent?
Background Experience:
- Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred.
- Minimum of 6 years of experience in Regulatory Affairs, of which a minimum of 4 years must be in IVD Regulatory Affairs.
- Regulatory Affairs Certification preferred.
- Experience in regulatory submissions including 510(k) and IVDR technical documentation required.
- Experience in international registrations preferred.
- Project management experience preferred.
- Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
- Advanced knowledge of regulatory intelligence tools and methods, with ability to interpret and apply regulations. Knowledge of electronic publishing/file management system.
- Advanced verbal and written communication skills including proofreading, scientific writing, presenting positive persuasive arguments, 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 analytical skills with ability to develop proactive and creative approaches to problem-solving including creating regulatory strategies that balance short and long-term objectives.
- Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.
Salary : $120,000 - $175,000
