Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combinati...

Job Description
The Associate Director, Regulatory Affairs, Strategic Global Labeling – Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation. This individual has influence within the department and is recognized as an expert resource on combination product and device labeling topics. They ensure that combination product and device labeling data are identified, evaluated and effectively presented for registration worldwide. The individual represents the organization at Senior level meetings regarding combination product and device labeling, including Target Product Label (TPL), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (SmPC), Instructions for Use (IFU), and other documentation for healthcare providers and end user. Under the Director of Strategic Labeling, they establish combination product and device labeling procedures and policy compliant with changing regulatory environments;
manages, develops, and supervises labeling Strategists.
Responsibilities:
Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team (e.G., 510(k) premarket notifications, Premarket Approval (PMA) applications, Investigational Device Exemption (IDE) applications, Medical Devices Regulations (MDR), Notified Body requirements, CE Mark, In-country notifications, etc.).
Work cross functionally with teams to support combination product and device submissions and seek clarification on regulatory requirements;
provide regulatory guidance and support to internal stakeholders, including Label Sub teams, R&
D, Quality Assurance, Human Factors, Operations S&
T, Manufacturing, Ad Promo and others as needed.
Review and interpret regulations and standards related to combination products and devices to ensure compliance with applicable laws and regulations related to safety and effectiveness.
Drive strategic labeling processes within teams based on knowledge of product class;
provide and recommend optimal labeling language based on evaluation and knowledge of project data.
Present proposed labeling at Senior level meetings including Executive Labeling Committee and others as required for product milestones and Health Authority interactions, ensuring that Labeling Sub team-endorsed strategies are efficiently implemented, endorsed by Senior Leadership, and aligned with changing regulatory and business needs.
Participate in the development and implementation of regulatory strategies for new product development, stay current with Global industry trends and best practices in combination product and device regulatory affairs, review and comment on changing regulation and guidance.
Provide training and development opportunities to direct reports, manage, and oversee Strategist work to ensure alignment with company goals and expectations.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)