Regulatory Affairs Project Management Specialist

**REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST**:
At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reinvent 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.

We are searching for the best talent for REGULATORY AFFAIRS PROJECT MANAGEMENT SPECIALIST to be in LATIN AMERICA (Mexico or Peru or Argentina or Brazil or Panama or Colombia).

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**Purpose**:
This role acts as project manager on regional impact projects related to process improvements, regulatory compliance, and quality assurance on the regulatory affairs team, participates as an SME on global impact projects that require RA MedTech LATAM input. Makes sure that alignments and initiatives are deployed among RA Team and processes are harmonized working closely with the RA LATAM QC PoC and local RA QC PoCs.

Your ability to build and maintain positive relationships with internal and external local, regional, and global business partners, and generating alignment agreements will be important

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**Key Responsibilities**:

- Act as project manager on regional impact projects related to regulatory compliance and quality assurance on the Regulatory Affairs MedTech team.
- Leads alignment and process improvement initiatives for the RA LATAM team, to gain efficiencies on RA team daily workload.
- Act as SME for global impact projects that require Regulatory Affairs MedTech LATAM input.
- Supports RA Operational Excellence manager on compliance-related activities as required.

**Qualifications**

**Qualifications**:
Education: University/Bachelor´s Degree or Equivalent within a technical related field. Can be a person with related experience and/or training or equivalent combination of education and experience, including a Master’s Degree or postgraduate diploma.

Experience: 4-6 years of related experience on the regulatory affairs area. Experience on Medical Devices industry is desirable. Experience with the preparation, submission, and approval of regulatory documentation for medical devices or pharma.

Certifications: RAC is a plus, Certification in project management is a plus (PMP certification or similar).

**Knowledge required**:

- Demonstrates a proven understanding of the LATAM regulatory environment, including compliance, current and proposed laws, regulations and guidance, to lead compliant regulatory projects that are aligned with R&D and business objectives of the company, including consideration of the global regulatory environment.
- Understands regulatory impacts and is able to communicate and guide internal teams and stakeholders on the decision-making process.
- Demonstrates the ability to contribute to the development of effective regulatory strategic plans that are in line with business objectives.
- Is aware of and receptive to cultural differences across regions and countries.
- Serves as a technical expert within job function

Soft skills: Quality Assurance mentality, Strong interpersonal skills, Project management skills (leading projects and working in simultaneous projects), Problem solving skills and critical thinking, Strong communication skills (verbal and written), Attention to detail, Familiar with data management and analytics concepts and tools

**Languages: Spanish native/advanced; English advanced; Portuguese is a plus**:
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Want to be part of something great?

Don't forget to apply. We want you

**Primary Location**
Mexico-Distrito Federal-Mexico City
- **Other Locations**
Latin America-Argentina-Buenos Aires, Latin America-Peru-Lima-Lima, Latin America-Colombia-Distrito Capital de Bogotá-Bogotá, Latin America-Brazil-São Paulo-São Paulo, Latin America-Brazil-São Paulo-São José dos Campos, Latin America-Panama

**Organization**
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