Sr Sup Regulatory Affairs - Medtech - Orthopedics

Johnson & Johnson; São Paulo; Híbrido; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global healthcare leader is seeking a Senior Supervisor in Regulatory Affairs based in São Paulo, Brazil. This role requires strong leadership skills for managing regulatory submissions and influencing strategy on medical devices. The ideal candidate must have over 5 years of experience in a regulatory environment and a Bachelor’s Degree in a relevant field. Fluency in English is mandatory, and knowledge of tools like Power BI is desirable. This position offers a hybrid work model and engagement with diverse teams and stakeholders.

Qualificações

• Minimum 5 years of experience in a regulatory environment with complex product submissions.
• Proven experience with medical devices.
• Experience with orthopedics products is desirable.

Responsabilidades

• Lead the team and oversee performance evaluations.
• Coordinate regulatory submissions and strategy.
• Manage quality issues and compliance.
• Act as a legal representative of the company.

Conhecimentos

Knowledge of local & international regulation

Analytical capability

Problem solving skills

Planning, organizing and prioritization skills

Effective communication

Compliance adherence

Interpersonal skills

Strategic thinking

Formação académica

Bachelor's Degree in Engineering, Pharmacy or other life science

Ferramentas

Power BI

Power Automate

Power Apps

Descrição da oferta de emprego

Function

Regulatory Affairs Group

Sub function

Regulatory Affairs

Category

Senior Supervisor, Regulatory Affairs (PL6)

Location

São Paulo / Brazil

Date posted

Jun

Work pattern

Hybrid Work

Job Description

Coordinates and ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously.

At this role, the professional will :

• Lead the team elaborating goals and objectives, supporting development plan and performing performance evaluations.
• Coordinate the work of RA Specialists to ensure submission is done properly and in a timely manner and that systems are being updated correctly.
• Coordinate and guide regulatory strategy of changes, new registrations and renewals, elaborating mitigation plans and serving as a technical expert within the job function.
• Coordinate activities to obtain or update establishment registration licenses.
• Coordinate with regional team on product submission schedules, prioritization, and pipeline management and escalates critical situations.
• Act as a point of contact for stakeholders to support business plans and regulatory needs.
• Coordinate implementation of new regulations.
• Guide the review of promotional materials according to MOH regulation.
• Lead or participate in meetings with Trade Associations and Health Authority.
• Scan and influence the external environment.
• Represent the area in internal and external audits.
• Elaborate and review procedures of the area.
• Coordinate team meetings and elaborate agenda and minutes.
• Coordinate acquisitions and divestitures.
• Manage quality issues.
• Act as point of contact for change controls.
• Coordinate compulsory certification and GMP activities.
• Select and manage external consulting services to prepare files in the same conditions as internal procedures as needed.
• Act as legal representative of the company.

It is expected that this person is solid in :

• Knowledge of local & international regulation and processes of medical devices.
• Analytical capability.
• Problem solving skills.
• Planning, organizing and prioritization skills.
• Communicates clearly, succinctly and effectively.
• Understanding the importance of compliance adherence.
• Solid interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive.
• Be strategic, think out of the box.

And it is expected to be proficient in :

• Collaboration and teaming.
• Results & performance driven.
• Sense of urgency.
• Integrity & credo-based actions.
• Intellectual curiosity.
• Self awareness & adaptability.
• Organization and talent development.

Must have at least 5 years of experience working in a regulatory environment, preparing submissions for complex products and a successful track record, and must have experience with medical devices.

Desirable experience with orthopedics products.

Bachelor's Degree in Engineering, Pharmacy or other life science.

English is mandatory and Spanish is desirable.

Desirable knowledge of Power BI, Power Automate, Power Apps, etc.