Sr. Regulatory Affairs Manager - Product Management

Teleflex - Morrisville, NC

Full-time - Mid Level

Morrisville, NC

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• Oversee the development and execution of regulatory strategies for new product development, including classification and pathway selection.
• Provide leadership for the team including performance management, Key Talent Development, succession planning, and employee development.
• Partner with R&D, Clinical, Quality and Design Assurance, Legal, and Marketing teams to ensure alignment on regulatory strategy, submissions, product lifecycle planning and compliance activities.
• Oversee the preparation, review, and submission of regulatory documents to regulatory authorities and domestic and other international agencies.
• Manage negotiation and maintain interaction with regulatory authorities worldwide during the development and review/queries process.
• Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes.
• Ensure preparedness and support of regulatory agency audits, inspections, and interactions.
• Monitor impact of changing evolving global regulations on submissions and communicate to internal stakeholders.
• Provide regulatory due diligence and integration strategies for mergers, acquisitions, and partnerships.
• Maintain organized and up-to-date regulatory files, records, and documentation.
• Comply with Teleflex's Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.

Requirements

• Bachelor's degree in science, engineering, or related field of study; equivalent experience may be acceptable in lieu of a degree.
• 7 to 10 years of related Medical Device Regulatory Affairs experience, with Class I and II devices; Class III experience is preferred.
• 5-7 years of leadership experience with proven ability to lead and motivate others.
• RAC certification is a plus.
• Demonstrated leadership skills and ability to apply business and Regulatory Affairs ethical standards.
• Excellent analytical and critical thinking skills to develop creative solutions and meet objectives.
• Strong verbal, written, and presentation skills.
• Ability to partner with and influence others without direct authority, build consensus, and manage multiple priorities.

Nice-to-haves

• Experience with Class III medical devices.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook.