International Regulatory Specialist at Teleflex
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Morrisville, North Carolina
MAJOR DUTIES AND RESPONSIBILITIES:
1.Coordinates and prepares moderately complex regulatory submissions, leveraging 510(k) premarket notifications, EU MDD/MDR Technical Files/Design Dossiers, and/or other documentation required for worldwide registration/licensure of products outside the U.S. Interfaces as needed with Teleflex International in country RA regarding submissions for new products and significant changes to products.
2.Collects international regulatory impact assessments from in-country SMEs and relays the information to design teams related to International requirements.
Serves as International RA team member for promotional materials review and product labeling as they relate to international registration and commercialization of medical devices.
Reviews product development to assure collection of appropriate data for international regulatory submissions and international regulatory compliance. Identifies use of appropriate International standards.
3.Participates in business interactions and negotiations with international regulatory agencies on requirements, formats, labeling claims, etc.
4.Monitors international government agency laws and regulations through websites and publications.
5.Provides support to more senior RA staff and performing other related duties and assignments as required.
6.Providence guidance to junior members of the International Regulatory Affairs staff
7.Brings International Regulatory Affairs questions/issues to the attention of Surgical RA management.
1.Orientation for detailed work with emphasis on accuracy and completeness
2.Effective written and oral communication skills
3.Good organizational and planning skills; drives for results
4.Effective analytical/problem solving skills
5.Good interpersonal skills that include working well in a team environment and the ability to lead others.
6.Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
7.Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
8.Working knowledge of international requirements and quality systems.
9.Ability to identify areas of Computer Literate: Microsoft Office PC, Word, Excel PowerPoint
1.Minimum of a Bachelors Degree
2.Minimum of 2-5 years experience working in a FDA or ISO regulated environment.
3.The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology.
4.Significant previous experience authoring and supporting submissions through final reviews for a medical device manufacturer
1.Internal Office environment
2.Travel less than 10%
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex is a medical device company specializing in General, Cardiovascular, ENT and Orthopedic instrumentation as well as ACT2 container systems. Our premier brands include Pilling, Weck, and KMedic. Teleflex also offers N-COMPASS , a software-based Instrument Management System.
PRINCIPAL OBJECTIVE OF POSITION:
Includes the following other duties may be assigned.
Creates and executes regulatory strategies and submissions for ROW registrations, leveraging US and EU clearances for license compilations.
The candidate will participate in any resultant compliance activities, resulting from the registrations..