Regulatory affairs executive role
the key objective of this position is to provide strategic leadership and oversight in all regulatory aspects related to our medical device portfolio. This will involve collaborating closely with cross-functional teams to develop and execute regulatory strategies that align with business goals and ensure compliance with applicable regulations and standards.
this role requires the ability to think strategically, analyze complex data, and communicate effectively across various stakeholders.
main responsibilities:
* develop and implement regulatory strategies for the successful development, registration, and commercialization of medical devices in the us market.
* provide regulatory guidance and expertise to cross-functional teams, including r&d, quality assurance, clinical affairs, and marketing, throughout the product lifecycle.
* assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factor study, and clinical trial designs to ensure compliance.
key qualifications:
* strong understanding of fda regulations and guidelines.
* proven experience in developing and executing regulatory strategies.
* excellent communication and project management skills.
benefits:
this role offers a competitive salary and benefits package, as well as opportunities for professional growth and development.