Teleflex - Morrisville, NC
posted 29 days ago
The Senior Manager, Regulatory Affairs at Teleflex is a pivotal leadership role that requires a comprehensive understanding of global regulatory requirements and a proven track record in navigating complex regulatory landscapes. This position is integral to the company's growth and reputation within the medical device industry, as it involves leading regulatory strategies, submissions, and compliance initiatives. The Senior Manager will collaborate with cross-functional teams to ensure alignment on regulatory strategies, submissions, product lifecycle planning, and compliance activities. This role is not only about managing regulatory submissions but also about fostering a culture of compliance and excellence within the organization. In this role, the Senior Manager will oversee the development and execution of regulatory strategies for new product development, which includes determining classification and pathway selection for various regulatory submissions such as 510(k), PMA, and De Novo. The position also entails providing leadership for the regulatory affairs team, focusing on performance management, talent development, and succession planning. The Senior Manager will be responsible for preparing, reviewing, and submitting regulatory documents to various authorities, ensuring that all submissions comply with relevant regulations and guidelines. Additionally, the Senior Manager will manage negotiations and maintain interactions with regulatory authorities worldwide, ensuring that submissions receive the necessary approvals and clearances. This role requires a proactive approach to assessing and managing risks associated with products and regulatory changes, implementing risk mitigation strategies as needed. The Senior Manager will also ensure the organization is prepared for regulatory audits and inspections, facilitating document requests and coordinating responses to findings. Furthermore, the position involves monitoring the impact of evolving global regulations and communicating these changes to internal stakeholders, as well as providing regulatory due diligence for mergers and acquisitions.