Job Description

Primary Function of Position:

The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. The Regulatory Affairs Lead liaises with cross-functional organizations, as well as global regulatory counterparts, focusing on product lifecycle management, including supporting ongoing product changes and continuous improvement projects. The Regulatory Lead is an regulatory SME on the product group, including classifications, indications, applicable regulatory standards and guidance documents, emerging regulations, and regulators and industry perspectives for the product group

Roles & Responsibilities:

• Provide regulatory guidance and direction, including potential risks, to cross-functional business partners and company leadership. Creatively identify risk-based solutions and strategies for problem-solving.
• Develop and recommend strategies for new product development and changes to products, including alterations to design, materials, labeling, packaging, manufacturing processes, and facilities.
• Support product engineering and manufacturing teams on regulatory issues, including reviewing design input, risk management, and test documentation.
• Assess the impact of product/process changes and determine regulatory pathways for the U.S. and Canadian markets.
• Lead, plan, coordinate, and prepare U.S. and Canada regulatory submissions of various types, including Pre-sub, FDA 510(k) premarket notifications, internal "Letters to File,", Canada license application, and amendment, etc., as applicable.
• Act as the core team RA functional lead, serving as a liaison between cross-functional teams and international counterparts for the rest of the world (ROW) regarding the impact of changes and working with international counterparts to coordinate global regulatory submissions/approvals and implementation roll-out.
• Provide risk-based guidance and strategic input into projects and issues, facilitating cross-functional alignment and resolution.
• Offer technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams.
• Perform other duties as required.