Analyst Regulatory Affairs- Fixed term 12 months
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
São Paulo BrazilJob Description:
Main Responsibilities:
- Serve as the main interface of Regulatory Affairs with Commercial Quality handling non-conformance change controls and procedures as well as providing all applicable support to local and international audits/ inspections especially from ANVISA INMETRO and MDSAP.
- Responsible for verifying product codes that have local ANVISA product license and determining which variations can be imported. Interface with regional LATAM Reg. Affairs team to release the applicable product versions.
- Analysis of promotional materials according to ANVISA regulation.
- Execute post-approval activities such as preparation of communications to stakeholders labels and Instructions for Use and system updates.
- Interacts with other JJ stakeholders government agencies in a professional decisive & articulate manner.
- Act as a point of contact for stakeholders to support business plans and regulatory needs.
- Review labels compliance in internal system.
- Support implementation and regulatory assessment of new regulations.
- Lead projects or support projects as representative of the subject/country.
Qualifications:
- Previous experience in Regulatory Affairs in Medical Devices (or Drugs/ cosmetics and food).
- Knowledge of Local Regulations from Medical Devices (or Drugs/ cosmetics and food).
- Bachelors Degree in Engineering Pharmacy or other life science related.
- Strong analytical and investigation skills.
- Strong prioritization and collaboration skills.
- Advanced level of English. Spanish will be a plus.
- Desirable experience in Medical Devices ANVISA and INMETRO regulations.
- Desirable experience in Quality such as non-conformances audits change controls and procedures
Required Skills:
Preferred Skills:
Analytical Reasoning Business Behavior Business Writing Collaborating Communication Confidentiality Data Reporting Data Savvy Detail-Oriented Execution Focus Legal Support Medicines and Device Development and Regulation Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk AssessmentsRequired Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
