Medtronic International Regulatory Affairs Specialist in Mansfield, Massachusetts
International Regulatory Affairs Specialist
Mansfield, Massachusetts, United States
Aug 04, 2017
INTERNATIONAL REGULATORY AFFAIRS SPECIALIST
Careers that Change Lives
Working on the regulatory team for Renal Care Solutions (RCS). This role supports successful approval for new and existing products introduced to foreign and domestic markets.
A Day in the Life
The International Regulatory Affairs Specialist is responsible for the creation and maintenance of International registrations.
Specific activities include but are not limited to:
Prepare and maintain regulatory international submissions (i.e. STED, country specific documents/forms) to obtain international regulatory approvals
Prepare appropriate export application forms for products intended to be exported to foreign countries (CFG/FSC, Certificate of Exportability)
Maintain country specific site registrations requirements (QSD, KGMP, Plant Master Files)
Maintain and provide regulatory information in support of customer queries, bid and tender submissions, custom queries
Understand and recommend strategies based on current local registration requirements and applicable industry standards.
Maintain and update InSight database (used for tracking Medtronic Worldwide Product Registrations)
Act as liaison between Medtronic and International Regulatory partners to address questions and issues that arise as part of the registration and/or testing process
Assist US Regulatory Product Specialist to analyze product changes for impact to current global filings.
Interface with in-country RA
Support in-country RA by addressing questions and issues that arise as part of the registration and/or testing process
Updates InSight database
MUST HAVE: MINIMUM REQUIREMENTS
Bachelor Degree required
Minimum One year's Regulatory Affairs experience
Ability to create cross-functional partnerships
Ability to work collaboratively in a team environment
Effective oral and written communication skills
Effective problem-solving skills
NICE TO HAVE
Majority of Regulatory Affairs experience in Medical Device industry preferred
Bachelor Degree in scientific discipline preferred
The International Regulatory Affairs Specialist will report into the Principal Regulatory Affairs Associate for Renal Care Solutions (RCS). Interaction with cross-functional representatives from in-country RA will be frequent. Interaction with management at the Director and Manager levels will be intermittent.
Travel Time required, up to 5%
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 interact with a computer, and communicate with peers and co-workers.
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.
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
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.