Healthcare/ Regulatory Strategy Analyst
R&D | Remote Position
Position Details:
Umbulizer is a fast-growing and social impact-driven initiative looking for a talented individual to join our team. If you are someone who is passionate about technology and social impact, then this is the right place for you! When you join Umbulizer, you are joining a firm that will challenge you and invest in your professional development. You will be working in cross-functional teams with medical device experts , consultants, engineers and government bodies to accelerate Umbulizer towards its next phase of growth.
The strategy consultant is responsible for planning and executing activities necessary to finalize design changes, incorporate best manufacturing and supply chain practices, obtain and maintain regulatory approvals within the United States, work with key stakeholders and shape go to market strategy.
Basic Qualifications:
- Bachelor’s/Master’s degree in Engineering or Business
Commitment:
- 15-20 hrs a week for 3 months (could be extended based on performance)
- Paid Position
Preferred Qualifications:
- Strong Proficiency in using MS Excel , Powerpoint and Word
- Demonstrated outstanding academic performance and an aptitude for learning
- Attention to detail
- Strong record of initiative-taking and leadership in a work setting
- Resourceful, intellectually curious, empathetic, poised, high energy and mature
- Determined and Hardworking
- Ability to communicate complex ideas effectively – both verbally and in writing – in English
- Regulatory Affairs certification
Key Responsibilities:
- Gather requirements and analyze documentation
- Participate on Product development teams by providing strategy, timelines, and direction
- Summarize feedback and incorporate finding into relevant documents
- Provide daily updates on tasks and checkin with team
- Build commercialization strategy and asses impact of product changes on US regulatory strategy
- Review labeling, training, promotional, and advertising material
- Support post-market strategy and product launch