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Senior Regulatory Affairs Manager - Enabling Technologies

Louisville, CO 80027
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Senior Regulatory Affairs Manager - Enabling Technologies


Louisville, Colorado, United States

Requisition #:


Post Date:

5 days ago


**Louisville, CO**

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

**Career That Change Lives**

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 Enabling Technologiesproducts. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs, and to represent Enabling Technologies on corporate teams within broader Medtronic. The successful senior manager will be a strategic partner for our RD 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.

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

**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 Enabling Technologiesproducts 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**

+ Bachelors Degree with7+ years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility OR Advanced Degree with5+ 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**

+ Engineering or Advanced degree desired.

+ Proven track record of leading high performing teams

+ Ability to recognize and develop key talent

+ Site leadership setting and executing various site specific regulatory and program initiatives

+ 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

**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. Lets 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)

Travel up to 25%

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:

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

Salary Min:$139,200.00 Salary Max: $208,800.00
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.


Posted: 2021-02-23 Expires: 2021-05-17
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Senior Regulatory Affairs Manager - Enabling Technologies

Louisville, CO 80027

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