Regulatory Affairs Specialist 10/11/2017
JOB DESCRIPTIONAPPLY Opportunity:
The Regulatory Affairs Specialist will develop global strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction.
The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role.
Teleflex partners with Anesthesia professionals to promote high quality healthcare. For over 100 years, our comprehensive range of clinician inspired products from Arrow, Rusch and Hudson RCI have advanced the art of anesthesia by improving safety, procedural efficiency, and patient satisfaction. Our commitment is to continue this legacy of innovation and quality by providing world-class products, clinical education and support.
Coordinates and prepares moderately complex regulatory submissions, including 510(k) premarket notifications, EU Technical Files, and Canada Submissions. Also interfaces with and supports the Global Regulatory Support Team and Commercial Regulatory Team with documentation required for global regulatory initiatives and registration/licensure of products outside the U.S. Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products.
Provides regulatory expertise and oversight to design teams.
Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices.
Insures compliance with design controls and reviews design documentation to insure regulatory requirements are met.
Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale.
Participates in business interactions and negotiations with regulatory agencies on premarket submission requirements, formats, labeling claims, etc.
Monitors FDA and other government agency laws and regulations through websites and publications.
RA Specialist: Provides support to more senior RA staff, and performing other related duties
Sr. RA Specialist: Mentor RA specialists and support complex projects and submissions
Brings Regulatory Affairs questions/issues to the attention of RA management.
Bachelor s degree in a science or engineering field.
At least 2 years of overall Medical Device Regulatory Affairs experience, Domestic and/or International (May offer RA Specialist or Sr. RA Specialist based on experience.)
May travel internationally
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.