Pl. Regulatory Affairs Analyst

About Teleflex Incorporated Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives.
We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers.
Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.
Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.
For more information, please visit teleflex.com.
Latin America - The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico.
The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.
As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America.
Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary The Pl.
Regulatory Affairs Analyst is a developing-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents supporting new or existing product offerings.
The candidate must work effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazil clearances/approvals.
Principal Responibilities Understand regulatory processes, guidelines, and guidance documents and what they mean to the organization.
Communicate with internal stakeholders.
Interface with various departments to collect and organize required documentation materials.
Data entry, remediation, and maintenance of various regulatory databases.
Assist in compiling new or revised medical device submissions and dossiers for import permits.
Begin education on relevant domestic and Latin American regulatory requirements for medical devices.
Support the Regulatory Impact Assessment process.
Discuss about GAP Assessments regarding regulatory updates.
Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.
Perform regulatory due diligence process Manage INMETRO certificates Lead local projects with orientation.
Education / Experience Requirements English proficiency is a Must - written and verbal skills.
Bachelor's degree in a science or engineering field.
Minimum of 5 years experience with Class I or II medical devices Experience with Class III or IV medical devices (preferable) Experience in INMETRO certification (preferable) Specialized Skills / Other Requirements Strong communication skills (verbal and technical writing).
Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality.
Strong organization skills, multi-tasking, meeting deadlines, and being detail-oriented.
Knowledge of electronic document management systems.
Ability to apply Business and Regulatory Affairs ethical standards; analytical and critical thinking skills.
Hability to manage the tasks and meet the deadlines.
Proficient in MS Word, Excel, PowerPoint, and Outlook.
Preferred:
understanding of domestic and international medical device regulations.
Travel Required Up to 10% 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:
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Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose.
Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
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