Our client is a Fortune 500 company and global leader in consumer products and medical devices who offers a wealth of career growth opportunities that allows you to reach your full potential. Our client is actively seeking for a Regulatory Affairs Manager to manage Latin America based in Mexico.
JOB POSITION PURPOSE/SCOPE
- Provides SME Regulatory Leadership for Responsible/Assigned Region/Countries; the Regional Focus is LATAM (Latin America)
- Gathers data and required documents for international submission purposes as well as maintains Regulatory databases for ready reference of international and domestic regulatory staff
- Applies technical quality and regulatory protocols and methods to ensure activities are in compliance with company standards and regulatory requirements.
- Prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements.
- Execute tasks and play a consultative role by partnering across internal business functions.
- Lead discussions with Regulatory Bodies in Latin America.
- Manage interactions with the in-country distributors regarding product registrations, Regulatory Compliance, Quality Compliance, and Post Market Reporting.
- Support product import/export into the Region.
- Effectively communicate, prepare, and manage regulatory submissions, and must assure that deadlines are met
- Execute and manage technical and scientific regulatory activities
- Provide Post Market Support for the Region
- Maintain internal databases with latitude for process/business improvements
- Exercise some latitude in determining technical objectives of assignments
- Remain current on Regional and International Regulations and Standards in accordance with role and/or projects
- Provide RA leadership to assigned project teams
KEY RELATIONSHIPS/ CUSTOMER EXPECTATIONS
- LATAM Business (Regional Management, Regional Distributors, Alpharetta based RA/QA and Post Market)
- Internal Departments needing quality and regulatory services and support (Marketing, Regional Management, Customer Service, Quality, Regulatory, Operations/Manufacturing, Research & Engineering, etc)
- External Regulatory Bodies in LATAM
KEY LEADERSHIP BEHAVIORS
- The incumbent shall demonstrate an open and candid attitude with their peers and be able to value diverse perspectives and debate
- The incumbent shall be able to prioritize tasks to drive results in a timely manner
- The incumbent shall be able to understand and anticipate customers’ needs and drive innovation in the compliance area
- The incumbent shall be able to develop and coach his team and be accountable for the strength and diversity of the team. The incumbent shall be able to coach other personnel in the compliance area to improve practices and behaviors across the company.
- A Bachelor´s degree in a relevant discipline and 6-10 years of experience in the medical device industry.
- Close working relationships with Business, Marketing, Manufacturing and Research functions, and in-depth knowledge/application of relevant international regulations.
- Demonstrated computer skills and strong written and verbal communications, and International submission experience preferred.
SPECIALIZED OR ESSENTIAL KNOWLEDGE REQUIRED
General knowledge of Regulatory requirements as:
- LATAM regulatory requirements
- USA Regulations (21 Code of Federal Regulation, FDA Guidelines, QSIT, etc.)
- European Regulation (ISO 9001, ISO 13485, ISO 14971, and etc)
- Good knowledge of Root Cause analysis and failure investigation tools
- Bilingual: English/Spanish
- English + a Secondary Language (Spanish and/or Portuguese) Physical Demands
- Medium international travel percentage (approximate 20 % of the time)