PM Eligibility, Rationalization, Compl

Johnson & Johnson MedTech; São Paulo; Híbrido; BRL 350 000 - 520 000; Tempo integral

Resumo da oferta

Johnson & Johnson is recruiting for a Regulatory Affairs Leader position based in Sao Paulo, Brazil, with alternate hybrid locations in Las Condes, Chile. The role supports global regulatory strategies, product eligibility assessments, and portfolio rationalization to ensure patient access and business continuity.

The candidate will collaborate across Regulatory Affairs, Quality, Supply Chain, and Commercial teams, driving lifecycle compliance and process improvements in a multinational setting.

Qualificações

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related discipline.
• Advanced degree or RAC/Quality certification preferred.
• Experience in medical device or life sciences regulatory/compliance.
• Knowledge of international regulatory frameworks.

Responsabilidades

• Lead and support product eligibility assessments to determine regulatory readiness and market viability across international markets.
• Execute portfolio rationalization activities, including analysis of regulatory, quality, and business risks to support informed decision-making.
• Ensure ongoing regulatory compliance of products throughout their lifecycle in alignment with international and local requirements.
• Partner with Regulatory Affairs, Quality, Supply Chain, and Commercial teams to align product strategies and timelines.
• Maintain and update product compliance documentation, trackers, and databases to ensure audit and inspection readiness.
• Support health authority interactions related to product changes, renewals, discontinuations, and remediation activities.
• Identify and drive process improvements to enhance efficiency, transparency, and consistency within eligibility and rationalization workflows.

Conhecimentos

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

Formação académica

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related discipline

Advanced degree or certification in Regulatory Affairs, Quality Systems, or Business Administration

Ferramentas

Regulatory systems

Descrição da oferta de emprego

Job Category

People Leader

At Johnson & J n, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com.

As guided by Our Credo, Johnson & J n is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & J n, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

People Leader

All Job Posting Locations

Las Condes, Santiago,, Region Metropolitana de Santiago, Chile, São Paulo, Brazil

Job Description

DePuy Synthes is recruiting for position, located in Sao Paulo, Brazil. Alternate Hybrid locations may be considered at Las Condes, Chile. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Sao Paulo, Brazil - Requisition Number: R-097924 Las Condes, Chile - Requisition Number: R-099896 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Overview

The PM Eligibility, Rationalization, Compliance role within QARA International plays a critical role in ensuring that DePuy Synthes products remain eligible, compliant, and optimally positioned across international markets. This position supports global and regional strategies by managing product eligibility assessments, driving portfolio rationalization activities, and ensuring ongoing regulatory compliance throughout the product lifecycle. The role offers strong cross-functional exposure and the opportunity to influence portfolio decisions that directly impact patient access and business continuity.

Key Responsibilities

• Lead and support product eligibility assessments to determine regulatory readiness and market viability across international markets.
• Execute portfolio rationalization activities, including analysis of regulatory, quality, and business risks to support informed decision-making.
• Ensure ongoing regulatory compliance of products throughout their lifecycle in alignment with international and local requirements.
• Partner closely with Regulatory Affairs, Quality, Supply Chain, and Commercial teams to align product strategies and timelines.
• Maintain and update product compliance documentation, trackers, and databases to ensure audit and inspection readiness.
• Support health authority interactions related to product changes, renewals, discontinuations, and remediation activities.
• Identify and drive process improvements to enhance efficiency, transparency, and consistency within eligibility and rationalization workflows.

Qualifications

Education

• Required: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related discipline.
• Preferred: Advanced degree or certification in Regulatory Affairs, Quality Systems, or Business Administration.

Required

Experience and Skills

• Experience supporting product management, regulatory, quality, or compliance activities within a medical device or life sciences environment.
• Working knowledge of international regulatory frameworks and product lifecycle management.
• Ability to analyze complex data sets to support eligibility and rationalization decisions.

Preferred

• Experience working in QARA International or global matrixed organizations.
• Familiarity with medical device regulations across Latin America and other international regions.
• Prior involvement in portfolio optimization, product discontinuation, or remediation initiatives.
• Experience using regulatory or product lifecycle management systems.
• Effective written and verbal communication skills for cross-functional collaboration.
• Strong organizational skills with the ability to manage multiple priorities and stakeholders.

Other

• Languages: Fluency in English required; Spanish strongly preferred.
• Travel: Limited domestic and international travel may be required (up to ~10%).
• Certifications: Regulatory Affairs Certification (RAC) or Quality certification preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & J n announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & J n is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & J n is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required 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

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