This position has the responsibility and authority to coordinate and prepares document packages for regulatory submissions including 510(k), original IDE and PMA submissions and supplements and similar clinical and market approval submissions worldwide; to recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance; to monitor and improve tracking / control systems; to keep abreast of new and changing regulations. May direct interaction with regulatory agencies on defined matters.
Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards, ISO 13485, MDD/MDR, CMDR etc.).
* Support New Product Development teams from project initiation through commercialization.
* Research, prepare, construct and submit documentation to support US, EU, and global regulatory product submissions
* Lead new and on-going reviews of marketing materials, go-to-market strategies and other commercialization activities as required to insure continued compliance to established product clearances
* Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company
* Provide support to currently marketed products as necessary. This includes reviewing engineering changes, labeling, product changes and documentation for changes requiring government approval.
* All activities must be performed in compliance with the Quality System.
* Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
* All other duties as assigned.
* Travel requirement: 10-20%
* Bachelor’s degree
YEARS OF EXPERIENCE
* 2+ years’ experience
s PECIALIZED KNOWLEDGE REQUIRED
* Bachelor’s Degree in life sciences or technical field
* Functional knowledge of US and key international regulations.
* Superior interpersonal, written communications, time management, and organizational skills.
* Demonstrated advanced software skills, including Microsoft Word, Excel, PowerPoint; Adobe Acrobat; and database skills.
* Ability to prioritize, conduct team meetings, and meet project deadlines.
* Experience working with technical documentation.
* Must be able to handle multiple tasks/projects and manage priorities accordingly.
* Working knowledge of submission structures and the medical device development process and related document requirements.
* Experience or coursework in regulation of medical devices or experience working with medical devices.
* Project management skills and experience.
PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job
* 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.
* While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers.
* Specific vision abilities required by this job include the ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* The noise level in the work environment is usually quiet to moderate.
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.
PHYSICAL JOB 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 Day in the Life 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.
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.uscis.gov/e-verify/employees
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.