Transformation RA Local Operations Specialist
Location:
Rio Rico , Arizona
Posted:
February 23, 2017
Reference:
000018YW/2-en-us

Medical Devices Segment- Johnson Medical


Our Medical Devices business segment produces a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopaedics, neurological disease, vision care, infection prevention, cardiovascular disease, and aesthetics.
Responsible for finalizing the preparation of Standard Technical Dossiers (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in Latin America countries.
Collects and prepares data to support the Transformation RA Sr. Specialists in the registration processes at the local level in Latin America. Assists with preparing necessary information for regulatory submissions and prepares general local documentation and forms, and processes legalizations and transactions required for final submission in countries as assigned.

POSITION DUTIES & RESPONSIBILITIES:

· Compiles information and documentation for routine submissions to Latin America regulatory bodies for multiple business units.

· Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.

· Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.

· Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.

· Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.

· Ensures compliance with regulatory agency regulations and interpretations.

· Prepares responses to regulatory agencies' questions and other correspondence as requested.

· Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

· Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

· Provides solutions to a variety of problems of moderate scope and complexity.


Qualifications
Functional and Technical Competencies
· Excellent communication skills (verbal and written) in English and Spanish

· Presentation skills

· Strong organizational skills

· Project management skills

· Problem solving skills



Leadership Competencies:

· Connect - Strongly influences others by partnering with them effectively; persists in the face of challenges.

· Shape: Challenge the status quo and adapting to change, taking advantage of opportunities to have a positive impact

· Lead: Utilizes strategic thinking and intellectual curiosity to generate effective ideas or solutions

· Deliver - Manages specific project steps to deliver required objectives independently/or with some supervision or as part of a team (for example, managing individual aspects of regulatory submissions).





EDUCATION & EXPERIENCE REQUIREMENTS:

• University/Bachelors degree or equivalent is required. Degree within a technical related discipline is preferred.

• 2 years of related experience is preferred.

• Ability to work both independently and in a team environment.

• Ability to problem solve, recognize and find solutions for gaps in processes

• A combination of background, education and experience can be considered.






Primary Location
Colombia-Distrito Capital de Bogotá-Bogotá
Other Locations
North America-United States-Puerto Rico
Organization
Johnson & Johnson de Colombia S.A. (7755)
Job Function
Regulatory Affairs

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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