Sr Regulatory Affairs Specialist

Medtronic
Posted

Post Expires

Type

Executive / senior industry position

Senior Regulatory Affairs Specialist - Cardiac and Vascular Group (CVG) Coronary and Renal Denervation (CRDN)The Senior Regulatory Affairs Specialist you will participate in the development of global pre-market Regulatory strategies and be responsible for submissions leading to approval of new Class III and/ or IIb (US/EU) products including but not limited to catheter-based technology to treat hypertension (renal denervation), coronary drug-eluting stents, and next-generation devices for percutaneous coronary interventions.Additionally, the Senior Regulatory Affairs Specialist develops strategies for worldwide medical device approvals to introduce new coronary and renal denervation products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with regulatory agencies.  The Sr. Specialist also assists with the training of other regulatory affairs associates and provides work direction and mentorship on projects of large scale  • Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for clinical studies and market release.  Review significant regulatory issues with management, as necessary, and negotiate submission issues with regulatory agencies.• Prepare regulatory strategies/plans and ensure compliance to worldwide requirements.  Provide on-going support to project teams for regulatory issues and questions.  Find, interpret and apply regulations and guidance appropriately for situations.• Provide business and product information enabling development of strategies and requirements and communicate project status and information to the management teams. Provide review of claims matrices and review advertising and promotion and training materials for new products. • Develops solutions to a variety of technical problems. Actively participates problem solving discussions and recommends solutions.• Frequent use and application of technical or regulatory principles, theories and concepts.  Recognizes and communicates problems that may affect the business or regulatory objectives.• Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance.  This includes reviewing labeling, promotional materials, training materials, changes to existing devices and documentation.  Prepare submissions and reports for regulatory agencies as required.• Complete understanding and wide application of technical or regulatory principles, theories and concepts.  General knowledge of other related disciplines.• Negotiate directly with the FDA or other regulatory bodies, as needed.  All significant issues will be reviewed with management.• Participate in the development of general strategies, including how to interact more effectively with regulatory agencies and agency personnel, including submissions and audits.• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.• Work under general supervision following established procedures. Independently determines and develops strategic approach.• Frequent inter-organizational and outside customer contacts. • Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.• Provide mentorship, training and support to other members of the department.• May travel: 10-20% The Cardiac and Vascular Group (CVG) brings all of Medtronic’s cardiac and vascular businesses together into one 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. Coronary and Renal Denervation (CRDN) products including but not limited to catheter-based technology to treat hypertension (renal denervation), coronary drug-eluting stents, and next-generation devices for percutaneous coronary interventions. 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.  

 

 • 4+ years of regulatory affairs experience or other relevant experience with a Bachelor’s degree• 2+ years of regulatory affairs experience or other relevant experience with a Master’s degree• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams.  

 

• In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, ISO 14971, ISO 13485, IEC 60601 and other global regulatory requirements and quality standards. Knowledge of new Medical Device Regulations (MDR).• History of successful device submissions• Knowledge of GLP/GCP requirements • Strong organizational skills and time management skills• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines• Ability to work independently and under general direction only • Strong communication skills

 

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 Cardiac and Vascular Group (CVG) brings all of Medtronic’s cardiac and vascular businesses together into one 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.Coronary and Renal Denervation (CRDN) products including but not limited to catheter-based technology to treat hypertension (renal denervation), coronary drug-eluting stents, and next-generation devices for percutaneous coronary interventions.

 

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.

 

 

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.

 

My Profile

 Regulatory Affairs

 Regulatory Affairs

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

“The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.”
“Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.”
“Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.”

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.

More Information

Posted

Post Expires

Type

Executive / senior industry position

Santa%20Rosa%2C%20United%20States

Santa Rosa , United States