Associate Regulatory Affairs Specialist
Santa Rosa, California, United States
Dec 05, 2017
Careers That Change Lives
Impact patient outcomes. Come for a job, stay for a career.
The Cardiac and Vascular Group brings all of our 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.
A Day in the Life
The Associate Regulatory Affairs Specialist provides regulatory support for domestic and international submissions; provides responses to routine requests for information or documentation for new or existing product support; interacts with various functional groups to ensure regulatory requirements are defined and adhered to.
•Team with other Regulatory Affairs Specialists to provide regulatory support for new products and changes to existing products. Activities include working with Specialists and other cross functional team associates to develop worldwide regulatory plans and deliverables list for new products and/or changes as required, working with global market managers to support in the development of regulatory plans for product registration (plans include required documents, testing and submission/approval schedules); reviewing documents required for submissions to ensure they are appropriate and accurate for submissions; working with Regulatory Affairs associates, engineers, and technical experts to resolve questions and issues; coordinating approval documents from countries.
•Provide regulatory support for post market activities for assigned product lines including, reviewing and approving Change Orders for assigned product lines in a timely manner.
•Develops solutions to routine problems of limited and moderate scope and complexity. Participates in planning and problem solving discussions.
•Limited use and application of technical or regulatory principles, theories and concepts
•Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
•Follows specific instructions and procedures for assigned tasks. Work is closely supervised.
•Communicates and interfaces primarily with immediate supervisor, project leaders, and other professionals within the regulatory group. Some interaction with other cross functional groups.
Must Have: Minimum Qualifications
YEARS OF EXPERIENCE:
•0 years of experience
Nice to Have
•Prior regulatory experience or exposure and knowledge of US and EU regulatory requirements
•Experience working with cross-functional team
•Experience working with technical documentation
•Effective negotiating skills and demonstrated written/technical skills
•BA/BS/Master’s degree in scientific or technical discipline
•Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel,
•Strong organizational skills
•Ability to multitask, support multiple projects, and meet project deadlines
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.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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.
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.
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