Sr Supervisor Regulatory Affairs
1 semana atrás
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
São Paulo, BrazilJob Description:
- Lead/ participate of meetings with Trade Associations and/ or Health Authorities, being responsible for Regulatory Shape activities. Coordinate implementation of new regulations from ANVISA, INMETRO and other authorities. Evaluates Public Consultations and coordinate participation of the company in important external regulatory events. Support implementation and regulatory assessment of new regulations and leads change controls related to such implementation.
- Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
- Act as a point of contact for internal stakeholders to support business plans and regulatory needs.
- Lead projects or support projects as representative of the subject/country.
- Coordinate regulatory actions related to acquisitions and divestitures.
It is expected that this person is solid in:
- Knowledge of Local Regulation on Medical Devices.
- analytical capability and problem-solving skills.
- planning, organizing and prioritization skills.
- communicates clearly, succinctly and effectively.
- understands the importance of adherence to compliance.
- solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
- Indirect leadership.
Requirements
- Must have at least 5 years of experience working in Regulatory Environment on Medical Devices (or Drugs).
- Strong knowledge of Local Regulations from Medical Devices (or Drugs).
- Bachelor's Degree in Engineering, Pharmacy or other life science related.
- Desirable experience in Trade Associations active participation for Medical Devices (or Drugs).
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Writing, Communication, Developing Others, Inclusive Leadership, Innovation, Leadership, Legal Support, Operational Excellence, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team Management-
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