Regulatory Affairs Manager

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

As the Regulatory Affairs Manager, you will be 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 Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement.

Location: Strong preference for candidates to be based out of Boulder, CO for a hybrid work arrangement. We can consider a candidate to be located near another Medtronic location or to work remotely from the U.S.

The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

Responsibilities may include the following and other duties may be assigned.

• Provides direction, leadership and coaching to specialists to meet schedules and resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
• Develop global regulatory strategies for Acute Care and Monitoring products to meet business objectives and collaborate across a matrixed organization to ensure global success of products.
• Collaboration with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategy with business objectives.
• Leading interactions with regulatory agencies as part of strategy development and support of regulatory reviews.
• Providing guidance on regulatory requirements necessary for contingency planning and ensuring compliance with all applicable regulations.
• Provide oversight of regulatory review of advertising and promotion materials to ensure appropriateness of product claims and materials in alignment with 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 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.
• Cultivates a safe, inclusive and engaging work environment
• Provide reports or present to Senior Management on progress to OU product submission goals on a periodic basis.
• Provide Regulatory Guidance as a functional leader on new product registration, modified products, transferred products, and acquisition activities.
• Continuously improve operating mechanisms, communication pathways and processes for efficiency
• Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
  
  
  

Required Knowledge and Experience:

• Bachelor’s Degree with 5 years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries with roles showing increasing responsability
  
  
  

OR

• An advanced degree with 3 years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries with roles showing increasing responsability
  
  
  

Nice to Have:

• 5 years of medical device regulatory affairs experience
• 1 year of previous experience with direct reports
• 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. 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
• 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 problem-solving skills and ability to work effectively in a collaborative team setting.
• Strong interpersonal, influence, communication, project management and negotiation skills.
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing design specifications and other technical documents
  
  
  

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

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.

Salary ranges for U.S (excl. PR) locations (USD):$114,400.00 - $171,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

About Medtronic

Medtronic benefits and compensation plans

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000 passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.