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Regulatory Affairs Manager Brain Modulation

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Regulatory Affairs
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19000H73 Requisition #

Regulatory Affairs Manager - RTG Deep Brain Modulation


 

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. 


 

Responsibilities:

• 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, 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.
• Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
• Drive product change assessments and define regulatory impact of product changes in global markets.
• Review and approve labeling, training, 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 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.


 

The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
 
BRAIN THERAPIES offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

 

Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
 

 

Come for a job.  Stay for a career.

Must Have: Minimum Requirements (Must be evident on the resume)

• Bachelor's Degree required.  Engineering or Advanced degree desired.
• 5+ years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility
• 3+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity
 
 
Preferred Qualifications:
 
• Engineering degree.
• Advanced degree.
• Excellent knowledge of U.S. and European/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
 
 
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. 
 
Physical 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 Position 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. 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).  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is required to be independently mobile
• The employee must be able to travel independently to various Medtronic buildings/sites.
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to travel by car and by airplane (<20%), including possible International travel
 
 
The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
 
BRAIN THERAPIES
offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
 
 
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

EEO STATEMENT:
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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

 
 
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
 
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