Senior Regulatory Affairs Manager at Medtronic in Irvine, CA

The Senior Regulatory Affairs Manager reports to the Regulatory Affairs Department leader and is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Neurovascular products. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs, and to represent the Neurovascular Operating Unit on corporate teams within broader Medtronic. The successful senior manager will be a strategic partner for our R&D and Marketing teams, as well as effectively collaborate with International RA, Clinical, Quality, Manufacturing Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle. The successful senior manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees. The senior manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role provides leadership, coaching and career development for team members and positively contributes to the development and maintenance of a collaborative and successful culture

A Day in the Life

• Provides direction, leadership and coaching to staff to meet schedules and resolve technical or operational problems. Develops and administers budgets, schedules, and performance standards. Becomes actively involved in daily operations to meet schedules or to resolve complex problems; responsible for personnel resource planning, forecasting and deployment.
• Develop global regulatory strategies for Neurovascular products to meet business objectives and collaborate across a matrixed organization to ensure global success of products.
• Participate on Product Development teams, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
• Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.
• Participate in Business Development due diligence teams and provide assessment of target to inform business decisions
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Drive product change assessments and collaborate with International RA team to define regulatory impact of product changes in global markets.
• Review and approve promotional and advertising material.
• Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, and international requirements.
• Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.
• Interpret and execute policies and procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.
• Participate on audit and field action teams.
• 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 from entry-level to Principal.
• Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations. Support meaningful development activities.

Must Have: Minimum Requirements

• Bachelor's Degree required. Engineering or Advanced degree desired.
• Minimum 7 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility or an advanced degree with minimum 5 years of experience in regulatory affairs in the medical device industry
• 5+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity

Nice to Have

• Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
• Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Must work well in dynamic and cross functional team environments
• Must demonstrate collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities
• Proven analytical abilities and utilization of system tools such as electronic document control systems (e.g., Agile, Master Control), familiarity with SAP or other ERP system, experience with electronic management of regulatory affairs data
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology; experience with vascular therapies preferred
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing design specifications and other technical documents
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Documented evidence of writing skills
• Basic understanding of computer applications; proficient in Microsoft Office Applications
• Familiarity with medical terminology
• Some overnight travel required