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Senior Regulatory Affairs Specialist
North Haven - Medtronic
SENIOR REGULATORY AFFAIRS SPECIALIST
Careers that Change Lives
Help streamline and speed our time to market and build quality in at every step. You will be a member of the product development team that supports the design and development of innovative, new products within the Surgical Innovations business. You can apply advanced technical concepts to complex problems from concept generation through early phase development.
Impact patient outcomes. Come for a job, stay for a career.
A Day in the Life
The Regulatory Affairs Sr. RA Specialist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities including but not limited to:
- Prepare, submit and maintain worldwide product regulatory filings
- Prepare, submit and maintain product specific dossiers per local country requirements
- Participate on PDP/CDP core teams and create Regulatory Strategies
- Under direction assist in preparation of documentation for product incident reporting
- Review of product labeling
- Under direction review of advertising and promotional material
- Maintain current regulatory knowledge by attendance at regulatory seminars and meetings
- Maintain current regulatory databases and produce various reports as needed
Since this is a diverse and location specific position, assigned responsibilities may be varied and not include all of the above.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Essential functions listed may not be all inclusive and maybe site specific:
- Organization and preparation of final regulatory filings (e.g. product submissions and site/establishment registrations)
- Under direction review change control documents and ascertain regulatory impact
- Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS)
- Requesting and routing registration fees to appropriate parties
- Collaborate with internal Covidien departments to develop test protocols and regulatory strategy
- Acting as liaison with International Medtronic Regulatory Personnel to address questions and issues that arise as part of the registration and/or testing process
- Establish and maintain a professional and credible image with regulatory agencies
- Maintains and updates TRAIN database (used for tracking Medtronic MITG Worldwide Product Registration)
- Understand and recommend strategies based on current local registration requirements and applicable industry standards
- Maintain knowledge of competitive technologies in addition to medical and technical developments related to the company's products
- Understand local country quality requirements (e;g. ISO, QSR)
Must Have: Minimum Qualifications
- Minimum 5 years' experience in Regulatory Affairs within the medical device marketplace
- Must have knowledge of U.S. and/or European/International regulations and standards
- Experience in preparing regulatory submissions
- Experience interacting with FDA and/or other regulatory agencies
- Bachelor's Degree in Scientific Discipline
- Proven experience leading onshore and offshore cross discipline teams.
Nice to Have
- Significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
- Knowledge of FDA regulations and TÜV requirements
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.
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. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
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