What are the responsibilities and job description for the Principal Regulatory Affairs Specialist position at Elixir Medical Corporation?
MAJOR DUTIES AND RESPONSIBILITIES
Responsibilities will include, but not be limited to:
- Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the company’s strategic objectives
- 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
- Work directly and interactively with cross functional teams during product development and production 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 and production processes
- Prepare and deliver effective presentations for external and internal audiences
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company
- Provide strategic guidance and regulatory support for the design and approval of nonclinical studies and clinical trials
- Provide regulatory support for post market activities/requirements
QUALIFICATIONS
Experience
- Bachelor's degree in Engineering or Science field
- 5 years of regulatory work experience in the medical device industry (3 in Class III Risk Devices)
- Prior experience with European regulations (MDR)
- Significant experience in leading and preparing major international regulatory submission projects and supportive amendments or supplements, and interfacing with regulatory authorities
- Experience in FDA submissions (clinical and market approvals)
- Experience leading and influencing project teams to attain group goals
- Experience in analysis, interpretation and extraction of important concepts from engineering/technical specifications and data, scientific information, international standards and government regulations
- Experience in writing reports and complex submissions (i.e., for PMDA, MFDS, TGA, ANVISA, CE Technical Files, etc.).
- Background in reviewing advertising and promotion materials
- Background in post market regulatory requirements
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel, including medical, scientific and manufacturing staff
- Excellent attention to detail and organizational skills
- Proficient at Microsoft Office suite of software tools
Salary : $115,000 - $150,000