Regulatory Affairs Manager - Enabling Technologies / CSF management Details

Regulatory Affairs Manager - Enabling Technologies / CSF management

Medtronic - Irvine, CA

Employment Type : Full-Time

Regulatory Affairs Manager - Enabling Technologies – CSF management

Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. We are the first company to offer an integrated solution that includes artificial intelligence-driven surgical planning, personalized spinal implants, and robotic-assisted surgical delivery to make patient care more customized.

CST is the market leader in spinal implants, robotics, and navigation. Our integrated operating unit is comprised of the following global businesses:

Spine and Biologics, offering full procedural solutions for spine surgery and bone grafting solutions for spinal fusion

Enabling Technologies, delivering an innovative portfolio that includes advanced imaging, navigation, robotics, customized implants, and pre-operative planning aided by artificial intelligence

China Cranial, Spinal Orthopedic Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics and orthopedics.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

The Regulatory Affairs Manager is responsible for establishing strategy for worldwide product approval submission activities, directly responsible for submission activities focused on US/EU and for ensuring regulatory compliance. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs. Collaborate with International RA, R&D, Marketing, Clinical, Quality, Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product lifecycle. Manages department activities with responsibility for results in terms of costs, methods and employees. Accomplishes results through hands on and delegation of responsibility to individual contributors. Provides leadership, coaching and career development.

A Day In The Life

• Provides direction, leadership and coaching to staff to meet schedules, resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
• Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products.
• Participate on Product Development teams as needed, providing input to regulatory strategies, timelines, and direction. Reviews and approves technical documentation.
• Oversee the organization and preparation of 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.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Understand product change assessments and define regulatory impact of product changes in global markets and communicate to key stakeholders.
• Review and approve labeling, training, promotional, and advertising material.
• Ensure compliance with Medtronic, U.S. FDA, and international requirements.
• Assist in reviewing, assessing impact and informing key stakeholders 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.
• Lead the regulatory team in the participation on audit and field action teams as well as support other post-market activities (e.g. CAPA, issue assessment).
• Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.
• Provide targeted career coaching and feedback. 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 (Must be evident on the resume)

• Bachelor's Degree required. Engineering or Advanced degree desired.
• Minimum 5 years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
• Or an advanced degree with a minimum 3 years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity

Nice To Have

• Engineering degree.
• Advanced degree.
• Experience with Electro-mechanical medical devices
• Excellent knowledge of U.S. and European (MDR)/International regulations and standards
• Experience interacting with FDA and/or other regulatory agencies
• 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
• Proven analytical abilities
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• 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

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)