Associate Director Regulatory Affairs

4 semanas atrás

São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro
At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are in this for life.
We are changing the trajectory of human health, YOU CAN TOO.
Would you like to work on the biggest health company in the world? Join us on this opportunity
**Overall **purpose **of **job**:
Exciting opportunity leading the MedTech Regulatory Affairs team, in Brazil. Work with other RA leaders and functions to ensure all marketed meet the regulatory requirements and provide the relevant support. Assign resources to complete submission plans and obtain timely approvals. Seek transformation of the regulatory environment through focused policy and advocacy initiatives, as well as business enabling activities. Supervise and handle related OPEX and Registration Fees budgets. Member of LATAM RA and Cluster Leadership Team.
**Essential **duties **and **responsibilities**:
- Lead RA function across countries in the cluster
- Ensure accurate prioritization of submissions to meet plan
- Head compliance with local regulations, Regulatory Authorities regulations and Enterprise Quality Standards
- Leading shaping environment initiatives in closed partnership with industrial associations
- Provide support and consultation to teams in other functions
- Ensures for the proper escalation & follow-up of concerns.
- Collaborate closely with Regional, Global and Franchise Regulatory Affairs teams, participate in working groups and projects, providing consultancy on all Regulatory Affairs related topics
- Support global and local level to develop and ensure implementation of RA SOPs
- Collaborate with other regional leaders to develop remediation plans within Regulatory Function and common strategies for the region
- Participate in and/or Lead regional/global Project Groups
- Provides Regulatory advice to local and regional Project Teams
**Qualifications**:
**Crucial **knowledge **and **skills**:
Education Level: University/Technical Degree or Equivalent,
Project management knowledge
Ability to build partnerships internally and externally
**Special **requirements**:
Language requirement: Spanish and English
10 years of experience within Regulatory Affairs (preferably in Medical Device sector) is required.
A minimum of 4-year experience in a people management position is required.
Knowledge of Medical Device requirements is required.
Previous experience in Medical Devices industry is preferred.
Experience and knowledge of local regulations and relationship with authorities, such as Anvisa and InMetro.
**Strengths **required **for **this **role**:
- People leadership skills
- Strong interpersonal, influencing and communication skills
- Ability to build partnerships internally and externally
- Organizational change experience
- Analytical and critical thinking
**Job **location**:
Sao Paulo, Brazil

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