Regulatory Affairs Specialist - New Brighton

Responsibilities:

??? Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products.
??? Team with business unit, Regulatory Affairs Specialists (RAS), and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
??? Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
??? Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
??? Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams.
??? Provide feedback and on-going support to product development teams for regulatory issues and questions.
??? Ensure personal understanding of all quality policy/system items that are personally applicable.
??? Follow all work/quality procedures to ensure quality system compliance and high quality work.

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.

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
??? 2+ years of US/EU medical device regulatory affairs experience with Bachelor's degree or 0+ years of US/EU medical device regulatory affairs experience with Master's degree
Preferred Qualifications: ??? Engineering degree.
??? Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
??? Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.
??? Experience with international standards (ISO, GHTF, ICH).
??? Experience in medical device acquisition due diligence
??? Excellent interpersonal skills.
??? Excellent oral and written communication skills.
??? Proficient computer skills (email, word-processing and spreadsheet software).
??? Effective cross-functional team player.
??? Good presentation skills.
??? Must be able to handle multiple tasks/projects and manage priorities accordingly.
??? Must have a high tolerance for ambiguity.
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 ( RTG (Restorative Therapies Group) Overview
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. 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: 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.