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

Elixir Medical does not discriminate on the basis of race, sex, color, religion, marital status, national origin, gender, sexual orientation, gender identity, age, military veteran status, disability or any other reason prohibited by law.