Regulatory Affairs Manager

Responsibilities

• Oversee the day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team.
• Become actively involved in daily operations to meet schedules or resolve complex problems.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, and collaborate across a matrixed organization to ensure the global success of products.
• Collaborate with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategies with business objectives.
• Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews.
• Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with all applicable regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
• Provide oversight of regulatory reviews of advertising and promotional materials to ensure that product claims and materials align with applicable local guidance and regulations.
• Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.
• Provide targeted career coaching and feedback; manage and develop team members at all levels of experience.
• Clearly identify and communicate talent differentiation, and ensure that development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations and support meaningful development activities.
• Cultivate a safe, inclusive, and engaging work environment.
• Provide periodic progress reports or presentations to senior management regarding OU product submission goals.
• Continuously improve operating mechanisms, communication pathways, and processes to increase efficiency.
• Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.
• Direct or perform the coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
• Lead or compile all materials required for submissions, license renewals, and annual registrations.
• Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
• Monitor and improve tracking and control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Required Knowledge and Experience

• Bachelor's degree required.
• Minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 years of relevant experience.

Preferred Qualifications

• Five or more years of medical device regulatory affairs experience.
• Degree in engineering or an advanced degree.
• Proven track record of leading high-performing teams.
• Ability to recognize and develop key talent.
• Excellent knowledge of U.S., European, and international regulations, including the EU MDR, as well as standards applicable to products of all risk classifications.
• Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions.
• Proven ability to prioritize work, manage time effectively, and meet project deadlines.
• Ability to work effectively in dynamic, cross-functional team environments.