Director, Regulatory Affairs
Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Develop and implement global regulatory strategies that support clinical research and marketing approvals in accordance with the company’s strategic objectives
- Work directly and interactively with cross functional teams during product development phases interpreting regulations, analyzing risks, and providing direction on test strategies and reviews thereof. Define strategies to mitigate risks
- Provide regulatory guidance to company personnel throughout the research and development process
- Direct the organization and prepare clear and effective submissions
- Prepare and deliver effective presentations for external and internal audiences
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company
- Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
- Provide leadership on project teams and subcommittees, as well as input to Senior Management teams
- Provide strategic guidance and regulatory support for the design and execution of nonclinical studies and clinical trials
- Coordinate meetings with regulatory agencies including rehearsals, moderating FDA meetings, and preparing briefing document and meeting minutes of these meetings
- Formulate and implement regulatory strategy, provide guidance, resolve complex issues related to assigned projects, and assure compliance with timelines and milestones to meet business needs
- Provide regulatory support for marketing and sales activities
Qualifications
Experience
- 12+ years of regulatory work experience (7+ in Class III Risk Devices)
- Extensive IDE/PMA submission experience
- Prior experience with European regulations (MDD, MDR)
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Background in preparing major global regulatory submissions and supportive amendments or supplements, and interfacing with regulatory authorities
- Ability to lead and influence project teams, committees, etc. to attain group goals
- Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel, including medical, scientific and manufacturing staff
Language & Verbal Skills
- Ability to read, analyze, and interpret engineering specifications, scientific information, professional journals, technical procedures, or government regulations
- Ability to write reports, specifications, and complex submissions (i.e. IDE, PMA, CE Design Dossiers, Technical Files, etc.)
- Ability to use MS Office products (Word, PowerPoint, etc.)
- Ability to effectively present information and respond to questions from internal and external regulatory agencies
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members and senior management
Math Skills
- Ability to work with statistical concepts
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Ability to use MS Excel to interpret project results/data
Analytical & Reading Skills
- Ability to define problems, collect data, establish facts, and draw valid conclusions
Education Requirements
- Bachelor’s degree in Engineering or Science field