Regulatory Compliance Strategist
A highly skilled Regulatory Compliance Strategist is required to spearhead and oversee all regulatory compliance activities for a medical device company.
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities, ensuring seamless global market access.
* Develop and lead the regulatory strategy for new product introductions and support existing products through their full lifecycle.
* Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations, fostering collaboration with cross-functional teams.
* Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe, maintaining effective relationships.
* Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance, driving proactive risk management.
* Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards, promoting excellence in quality.
* Review and approve promotional and advertising materials from a regulatory perspective, upholding brand integrity.
* Identify and allocate internal and external resources needed to maintain a robust regulatory function, streamlining processes.
* Provide strategic advice and cross-functional support on all regulatory matters, enhancing business growth.