Sr Regulatory Affairs Specialist

Medtronic
Posted

Post Expires

Type

Executive / senior industry position

Senior Regulatory Affairs Specialist - RTG Neuro - CSF

The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe.  This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes. 

• Participate on project teams, providing regulatory strategy, timelines, and deliverables• Prepare US and EU submissions.  Work with FDA, Notified Body, and regulatory geography support to obtain product approval/clearance.• Develop US and International regulatory strategies and timelines for product submissions; identifying needs for bench, animal and clinical testing• Review Change Orders and assess regulatory impact of product changes on US, EU and/or International regulatory strategy and submissions per standard procedures• Review labeling and assess compliance against relevant regulations and product requirements• Develop and maintain regulatory affairs department procedures and process improvements• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct• 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• Assist in keeping company informed of regulatory requirements in the US and EU.• Other tasks, as assigned.

 

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, strokes and aneurysms, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

 

This position is part of the CSF Team. CSF-Flow Control valves are fixed pressure valves. They’re part of a shunt system used to treat the symptoms of hydrocephalus. A shunt redirects excess cerebrospinal fluid (CSF) in the brain to another part of the body, allowing the brain’s enlarged ventricles to return to a more normal size.

 

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.

 

 

Must Have: Minimum Requirements (Must be evident on the resume)• Bachelor's Degree required.  Engineering or Advanced degree desired.• 4+ years of US/EU medical device regulatory experience with Bachelor’s degree (quality experience in medical device may substitute for some experience)  - OR -• 2+ years of US/EU medical device regulatory experience with Master’s Degree (preferably in Regulatory Affairs)• Knowledge of FDA and EU requirements • Degrees in Engineering or Regulatory Affairs preferred• Knowledge of FDA and EU requirements• Regulatory Affairs Certification• Strong technical writing 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 (<10% typically and no travel during the COVID-19 period)  RTG (Restorative Therapies Group) OverviewThe 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, strokes and aneurysms, as well as surgical technologies designed to improve the precision and workflow of neuro procedures. This position is part of the CSF Team. CSF-Flow Control valves are fixed pressure valves. They’re part of a shunt system used to treat the symptoms of hydrocephalus. A shunt redirects excess cerebrospinal fluid (CSF) in the brain to another part of the body, allowing the brain’s enlarged ventricles to return to a more normal size.  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. Come for a job.  Stay for a career.

 

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Posted

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Executive / senior industry position

Irvine%2C%20United%20States

Irvine , United States