Regulatory Affairs Manager
This role involves leading the development and implementation of regulatory strategies for global product entry and exit. The ideal candidate will have a deep understanding of regulatory requirements, including ISO, FDA, and international regulations.
The Regulatory Affairs Manager will be responsible for assessing links between global trends, stakeholder concerns, and regulatory issues. They will develop and update global, regional, and multi-country regulatory strategies, aligning them with organizational strategies.
Key areas of responsibility include:
* Developing and implementing regulatory strategies to expedite product development;
* Negotiating with regulatory authorities on complex issues throughout the product lifecycle;
* Establishing working relationships and interfaces with government and non-government organizations;
* Managing the development and execution of new regulatory procedures and standard operating procedures;
The successful candidate will have a strong background in regulatory affairs, with a minimum of 8 years of experience. A master's degree or equivalent is preferred, as well as knowledge of medical device product lines and demonstrated leadership skills.
Required skills and qualifications include:
* Strong understanding of regulatory requirements, including ISO, FDA, and international regulations;
* Technical knowledge of medical device product lines;
* Leadership skills, with the ability to effectively prioritize and manage multiple project workloads;
* Excellent communication and team-building skills;
* Demonstrated ability to collaborate effectively with cross-functional teams.
Benefits of this role include:
* Opportunities for professional growth and development;
* A dynamic and supportive work environment;
* Competitive compensation and benefits package.
Apply today to take your career to the next level!