Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

Lead a team of international regulatory affairs to ensure rapid and timely global registration on new and existing products within Advanced Surgical Technologies. Interacts with global regulatory affairs and business leaders in order to expedite approval of registrations so business continuity is maintained. Ensures business units are coordinating activities to expand global product registration, clearance, licenses, and approvals in a forecasted and planned manner so global patient access is maintained and expanded.

Position will lead pre-market submission and registrations for new and existing products for all international markets excluding US and EU. Coordinates across the Business Unit functions, Region Marketing, Country Marketing, and Regional Regulatory to register new products and maintain existing registrations and licensing.

Reviews, evaluates, monitors, measures and evaluate global registration activities to ensure that the registrations are successful and timely to ensure the pipeline of product is not interrupted.

Careers that Change Lives

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it's like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space

#MDTsurgicaljobs #MDTsurgicalregulatory

A Day in the Life

• Lead a team of 6-8 regulatory professional in support of global registrations

• Manage the Regulatory Affairs staff that supports Regions with needed documents and information for registrations and licenses.

• Prioritize international regulatory registrations based on business priorities

• Develop, implement, and improve upon processes, operating mechanisms, and department norms

• Partner with BU Marketing, Regional Marketing, and Regional Regulatory at mid and senior management levels to support the goals of the business in international market by forecasting and planning international submissions.

• Work with key functions such as R&D, Sustaining Engineering, Quality Assurance, Operations, Legal, and Regulatory Affairs to deliver needed documentation and support for international registrations. This support can include Type Testing, Standards Conformity documentation, Government documents, Technical Files / Dossiers or letters of authorization.

• Build a strategy for coordinating and planning activities with other functional groups to achieve international registrations / licenses as needed by the Business Unit.

• Monitor and measure progress to BU and Regional product submission goals on a periodic basis.

• Provide reports or present to Senior Management on status of the BU and Regions submissions, registrations, and licenses.

• Oversee the use of global submission management software systems (e.g., Calyx) for planning activities and provide feedback and direction to Regional RA for effectively and efficiently using the global submission software systems.

• Provide Regulatory Guidance as a functional leader and global registrations of new products, modified products, transferred products, and acquisition activities.

• Develop global registration strategy for international filings to expand the Served Available Market.

• Coordinate the collection of documents for premarket submissions, renewals, product changes and product transfers to new sites or contract manufacturers.

• Prepare materials for site registration for Regional Business Unit affiliates worldwide.

• Direct and manage multiple, sometimes conflicting priorities, including ensuring the company meets regulatory requirements.

• Lead, mentor and develop direct reports.

• Properly resource the BUs new and sustaining projects.

• Apply expertise to all direct departments and provide leadership to staff, cross-functional groups and business leaders.

• Establish and review Business Unit and RA priorities as they relate to department and company goals and objectives.

• Approve personnel hiring and development plans.

• Establish, review and approve bonus objectives for direct staff.

• Approve strategies for global Regulatory filings and compliance.

• Develop strategies as they relate to changes to approved devices.

• Continuously improve operating mechanisms, communication pathways, processes, and efficiency

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

• Monitors and improves tracking / control systems.

• Keeps abreast of regulatory procedures and changes.

• May direct interaction with regulatory agencies on defined matters.

• Additional tasks as assigned

Must Have: Minimum Requirements

• Bachelor's degree with 7+ years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of managerial experience

OR

• An advanced degree with 5+ years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of managerial experience

Nice to Have

• 10+ years of Medical Device regulatory affairs experience

• An advanced degree in Regulatory Affairs or a technical field such as engineering

• Ability to work in a global strategic framework, establish tactical plans and work in a self-directed manner to drive for results.

• Strong problem-solving skills and ability to work effectively in a collaborative team setting.

• Attention to detail with proven and effective leadership and command skills.

• Knowledge of regulatory environment and product regulation fundamentals, knowledge of international environment strongly preferred.

• Understanding of medical device industry procedures and terminology.

• Experience in Regulatory Affairs working with global submissions

• Strong interpersonal, influence, communication, project management and negotiation skills.

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)

Compensation

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.