Manager, 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
- Organize 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
- 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
- 5+ years of regulatory work experience in medical devices
- Prior IDE/PMA, CE mark, and/or APAC submission experience
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Background in preparing global regulatory submissions and supportive amendments or supplements, and interfacing with regulatory authorities
- Ability to work with project teams, committees, etc. to attain group goals
- 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 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 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
- Ability to read technical and clinical literature and documents and extract important concepts
Education Requirements
- Bachelor’s degree in Engineering or Science field