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Staff Regulatory Affairs Specialist

Job description

The Staff Regulatory Specialist 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 Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. Additionally, the position develops Regulatory strategies for new product development and design changes while representing regulatory interest in product development teams. The Staff Regulatory Specialist advises on the implementation of compliance mechanisms for new and emerging regulations, standards, and regulatory guidances. This position collaborates with personnel with the business unit and company.

Responsibilities
  • Design Control: Is Regulatory lead on cross-functional product development teams. Provide team with strategic and tactical guidance regarding global regulatory requirements to support product marketing authorizations. Review product design and change documentation, perform regulatory assessments, and implement required regulatory actions.
  •  Regulatory Projects: Independently lead multiple long-term projects. Interact with supervisor as required on activities, issues, or turning points. Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
  •  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.
  •  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. Develop 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 for accomplishing company goals and initiatives. Implement regulatory strategies and tactics. Manage regulatory consultants when engaged to assist with goals.
  •  Labeling, Advertising, and Promotion Review: Review and approve labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc. Provide regulatory review and approval for product marketing collateral.
  •  Quality Management System Support: Assist in the education and broadening the regulatory knowledge within 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.
  •  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.
  •  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.
Qualifications
  •  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 documentation required.
  •  Experience in international registrations required.
  •  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.