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Regulatory Affairs Manager Latin America 8/24/2016

Teleflex Morrisville, NC

Company
Teleflex
Job Classification
Full Time
Company Ref #
4040
AJE Ref #
575970061
Location
Morrisville, NC
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Opportunity:
Latin America product registrations and is responsible for leading regulatory staff in Latin America, preparing regulatory strategies, managing submissions and interactions with various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in specific area(s) of concentration (countries) as assigned.

Division Information:
The Corporate division is the central operating unit of the company setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. Company headquarters are located just outside of Philadelphia in Wayne, PA.

Position Description:
Manage day to day activities regulatory staff in Latin America
Participate as a member of the regulatory team within the business unit to implement the regulatory strategic plans.
Participate as a member of Technical Teams for new and/or existing products. Evaluate and interpret regulatory requirements to meet project needs.
Review and approve marketing literature for Latin America
Develop timelines, coordinate receipt of technical information from appropriate sources, and manage the preparation of submissions for new products, amendments of approved products and submissions that support the maintenance of existing licenses.
Manage the preparation of responses to regulatory agency questions and/or requests for information.
Review technical documents intended for submission.
Train, develop, and mentor co-workers as appropriate.
Develop regulatory strategies for product development and launch of moderate-complexity projects.
Conduct and analyze regulatory research for moderate-complexity projects to understand competitor activity and positioning, and translate to regulatory strategy.
Provide guidance to project teams for existing research and standard analysis.
Review technical and scientific data to ensure that it follows the regulatory requirements.
Apply understanding of the quality systems to job activities and projects.
Participate in training RA team members and others on compliance matters.
Communicate with regulatory agencies on
Standard Hours *

Group Lead
administrative and routine matters or to address questions on specific submissions.
Assist or lead the preparation and maintenance of moderate-complexity regulatory submissions while maintaining quality standards.
Prepare responses to standard questions and comments from regulatory agencies and ensure issues are addressed in a timely manner.
Identify any potential risks in submissions.
Interpret existing regulations and guidance documents within regulatory department and on project teams.
Understand regulatory processes, guidelines and guidance documents and what they mean to the organization.
Identify risk factors and contingency planning for assigned projects.

Requirements:
B.A. or B.S. degree in the life sciences, or similar field, may be substituted by extended experience in regulatory field
Minimum 7 years of medical device experience as a regulatory specialist in international regulatory affairs.

SPECIALIZED SKILLS & OTHER REQUIREMENTS: Additional preferred or required qualifications.
Spanish or Portuguese a plus
Knowledge and experience in Latin America registrations or one or more essential regulatory areas and marketing approvals; change assessment; advertising and promotional labeling; and quality systems.
Knowledge of, and ability to interpret, applicable in-country regulations.
General understanding of project management processes.
Excellent written and verbal communication skills and computer literacy.
Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality.

TRAVEL REQUIRED: 10%

Company Information:
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.