Associate Director Regulatory Affairs

Há 3 dias

Sao 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

  • Sr Regulatory Affairs Associate

    2 semanas atrás

    São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiro

    Sr Regulatory Affairs Associate page is loaded## Sr Regulatory Affairs Associateremote type: Onsite - Hybrid Eligiblelocations: Brazil - Sao Paulotime type: Full timeposted on: Posted Todayjob requisition id: R At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19...

  • Director, Regulatory Affairs

    2 semanas atrás

    Sao Paulo, Brasil PTC THERAPEUTICS Tempo inteiro

    Job Description Summary: **Job Description**: Location: Sao Paulo The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues. The Director, Regulatory Affairs supports adherence to relevant regulatory requirements and company SOPs as appropriate. ESSENTIAL FUNCTIONS - Leads the development,...

  • Sr Regulatory Affairs Associate

    1 semana atrás

    São Paulo, Brasil Gilead Sciences Farmaceutica do Brasil Ltda Tempo inteiro

    Description  Position: Regulatory Affairs Sr. Associate in São Paulo, Brazil We are looking for a regulatory affairs professional who is passionate about biotechnology and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an opportunity to join the Regulatory Affairs team built on a...

  • Sr Regulatory Affairs Associate

    1 semana atrás

    São Paulo, Brasil Gilead Sciences Tempo inteiro

    Join to apply for the Sr Regulatory Affairs Associate role at Gilead Sciences . At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across...

  • Regulatory Affairs Associate

    4 semanas atrás

    São Paulo, Brasil Teleflex Tempo inteiro

    Position Summary The Jr. Regulatory Affairs Analyst is an entry-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents in support of new or existing product offerings. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazil...

  • Regulatory Affairs Manager

    2 semanas atrás

    Sao Paulo, Brasil BD Tempo inteiro

    We're searching for a professional that will help us to build a strong and capable Regulatory Affairs Organization in Brazil to properly respond to the business needs. Sense and influence the external regulatory environment to anticipate new regulatory requirements, regulation and trends and map the impacts to BD. Develop and define the strategy to address...

  • Sr Regulatory Affairs Associate

    2 semanas atrás

    São Paulo, Brasil Getting Hired Tempo inteiro

    At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges,...

  • Sr Regulatory Affairs Associate

    Há 5 dias

    São Paulo, Brasil Gilead Sciences Tempo inteiro

    At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission...

  • Sr Regulatory Affairs Associate

    Há 4 dias

    São Paulo, Brasil Gilead Sciences Tempo inteiro

    Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest...

  • Director, Regulatory Affairs

    Há 3 dias

    Sao Paulo, Brasil Edwards Lifesciences Tempo inteiro

    Direct all Regulatory Affairs activities within the respective country(ies). As Head of LATAM, Manage and oversee assigned Regulatory Affairs activities within Brazil, South Latin America and other Latin America Countries and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies...