Regulatory Affairs Leader
The company is seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities.
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.
* Develop and implement regulatory plans for new product introductions and existing products throughout their lifecycle.
* Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations, ensuring compliance with evolving regulatory requirements.
* Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
* Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
* Review and approve promotional materials from a regulatory perspective.
* Identify and allocate internal and external resources needed to maintain a robust regulatory function.
* Provide strategic advice and cross-functional support on all regulatory matters.
Key Skills and Qualifications
* Bachelor's degree in Engineering, Life Sciences, or a health-related field.
* 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
* In-depth knowledge of US FDA and EU medical device regulations (including MDR).
* Proven ability to handle complex regulatory submissions and interactions.
* Excellent organisational, leadership, and communication skills.
* A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
* Previous experience in an SME or medtech startup is highly desirable.
Why Join Us?
* Work with a talented team of professionals.
* Contribute to the development of innovative medical devices.
* Opportunity to work in a fast-paced, dynamic environment.
* Competitive compensation and benefits package.