Regulatory Affairs Specialist
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 and help with our regulatory efforts. If you are someone who is passionate about technology and social impact, then this is the right place for you! The Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes, and specification changes.
Basic Qualifications:
- Bachelor’s degree
- 2+ years of US/EU medical device regulatory submission experience
Preferred Qualifications:
- 510(k) or PMA submission experience
- Knowledge of FDA and EU requirements
- Strong technical writing and communication skills
- Regulatory Affairs certification
Key Responsibilities:
- Develop FDA and EU regulatory strategies for product submissions, identifying needs for bench, animal, and clinical testing
- Keep company informed of regulatory requirements in the US and EU
- Participate on Product Development teams by providing regulatory strategy, timelines, and direction
- Prepare FDA and EU submissions, ensuring relevant ISO and regulatory requirements are met
- Review change orders and assess regulatory impact of product changes on US and/or EU regulatory strategy
- Review labeling, training, promotional, and advertising material
- Support post-market regulatory compliance activities for FDA/EU product approvals