Staff Regulatory Affairs Specialist - United States
- Develops global regulatory strategies for electro-mechanical and software product submissions.
- Develops and maintains domestic and international submissions.
- Reviews international and domestic labeling and marketing communications for compliance to labeling standards and product claims.
- Reviews and approves product design changes.
- Provides regulatory guidance to project teams including marketing, R&D and quality.
- Prepares and maintains domestic and international regulatory strategies and submissions.
- Participate as a core team member for development projects and works with cross-functional teams from multiple business units.
- Review and approves product design and change documentation, including development plans and ISO 14971 risk management deliverables.
- Reviews domestic and international labeling for compliance to labeling requirements, including content, format, regulatory submissions.
- Provides regulatory review and approval for domestic and International product marketing communications.
- Bachelor's degree and minimum of 5-7 years related professional experience; equivalent combination of education and experience.
- Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications. Knowledge of ISO / MDD and Canadian regulatory requirements.
- Experience with software driven electro-mechanical medical devices, stand-alone software and IEC 62304 software development lifecycle.
- Good prioritizing, organization, interpersonal, communication and analytical skills, Ability to influence and work with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)
- Language Skills: Ability to read, analyze, and interpret regulatory literature and documents.
- Ability to format regulatory submissions that conform to prescribed style and format.
- Ability to effectively communicate information to peers and management.
- Ability to translate regulations and guidelines into terms that employees can understand.
- Mathematical Skills: Ability to calculate figures and amount such as proportions, percentages etc.
- Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions, furnish in written oral, diagram, or schedule form.