Regulatory Affairs Director LATAM – Medical Devices (mfd)
Regulatory Affairs Director LATAM – Medical Devices (mfd)
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Job Description
JOB DESCRIPTION:
At Abbott were committed to helping people live their best possible life through the power of health. For more than 125 years weve brought new products and technologies to the world in nutrition diagnostics medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life. Today 114000 of us are working to help people live not just longer but better in the more than 160 countries we serve.
Abbott is currently looking to recruit a
Regulatory Affairs Director LATAM Medical Devices (m/f/d)
Based in São Paulo Brazil
This position is responsible for the development and direction of the Regulatory Affairs team in Latin America to obtain necessary approvals and licenses to increase and maintain the portfolio of following Medical Device divisions: CRM / EP / HF / SH / NM / VAS.
MAIN RESPONSIBILITIES:
Define regulatory strategies and align resources to execute essential regulatory tasks in a timely manner ensuring no business disruption in the region.
Provide the best regulatory solutions for each business model in the region covering both direct subsidiaries and multi-distributor networks.
Hire train and support the Regulatory Affairs team and determine the optimal organizational structure to meet group objectives.
Build strong relationships with Health Authorities and other external stakeholders. Act proactively with these Health Authorities in the region to shape and implement emerging regulations without business disruption. Monitor these new regulations analyze their impact determine implementation strategies and ensure proper documentation in company systems.
Maintain close collaboration with Marketing Operations and Sales teams to ensure compliant product launches according to local regulations.
Align team responsibilities and activities with the demands of business units and senior Regulatory Affairs leadership.
Ensure that Regulatory Projects in the region are properly managed and resourced to promote continuous improvement of regulatory processes.
Identify opportunities anticipate risks and enable effective contingency plans when necessary to achieve goals and accelerate opportunities.
Continuously monitor the competitive landscape and provide valuable regulatory insights for business planning.
Build personal credibility and strong working relationships capable of engaging and/or leading high-performance cross-functional teams.
Manage regional budget and resources.
Ensure compliance with activity metrics under your responsibility as well as internal/external customer satisfaction and implement corrective or preventive actions when necessary.
Conduct actions and decisions under your responsibility in accordance with the companys Code of Business Conduct.
Support EHS (Environment Health and Safety) policies and practices by participating in and promoting area initiatives.
EDUCATION:
Bachelors Degree in Biomedical Science Pharmacy Biomedical Engineering or a related field.
Fluent English & Portuguese intermediate/advanced level in Spanish
EXPERIENCE:
Minimum of 10 years of experience in Regulatory Affairs of medical devices.
At least 5 years of experience in a supervisory/managerial level with proven success in a highly matrixed environment.
Track record in working with trade associations in the region
COMPETENCIES:
Ability to build partnerships and collaborate across organizations regions and with external partners to achieve results.
Strong influencing skills with stakeholders across different areas/functions.
In-depth knowledge of Medical Device regulations in Latin America.
Excellent verbal and written communication skills.
Strong negotiation and persuasion abilities.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
Brazil > Sao Paulo : Rua Itapeva 538-5 ao 8 andares B
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Director
Employment Type
Full-Time
