PM Eligibility, Rationalization, Compl

Johnson & Johnson Innovative Medicine; São Paulo; Híbrido; BRL 240 000 - 420 000; Tempo integral

Resumo da oferta

Johnson & Johnson Innovative Medicine in Sao Paulo seeks a Regulatory Affairs professional to manage product eligibility assessments and portfolio rationalization across international markets. You will drive regulatory readiness, collaborate with cross-functional teams, and ensure ongoing compliance throughout product lifecycles.

The role requires a Life Sciences/Regulatory background, experience with medical devices or life sciences, and strong data analysis skills.

Qualificações

• Experience in regulatory, quality, or compliance activities within medical device or life sciences.
• Working knowledge of international regulatory frameworks and product lifecycle management.

Responsabilidades

• Lead and support product eligibility assessments to determine regulatory readiness and market viability.
• Execute portfolio rationalization activities considering regulatory, quality, and business risks.
• Ensure ongoing regulatory compliance of products across their lifecycle per international and local requirements.
• Partner with Regulatory Affairs, Quality, Supply Chain, and Commercial teams to align strategies and timelines.
• Maintain and update product compliance documentation and dashboards for audit readiness.
• Support health authority interactions related to product changes, renewals, and remediation activities.
• Identify and drive process improvements to enhance efficiency and transparency in eligibility workflows.

Conhecimentos

Regulatory affairs

Data analysis

Cross-functional collab

Lifecycle management

Formação académica

Bachelor's Life Sciences/Engineering

Ferramentas

Regulatory systems

PLM systems

Descrição da oferta de emprego

Sep 22, 2026

At Johnson & Johnson,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 & Johnson 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 & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

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):

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, Compliancerole within QARA International plays a critical role in ensuring that DePuy Synthes productsremaineligible, 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 strongcross‑functionalexposure and the opportunity to influence portfolio decisions that directlyimpactpatient access and business continuity.

Key Responsibilities

• Lead and support product eligibility assessments todetermineregulatory readiness and market viability across international markets.
• Execute portfolio rationalization activities, including analysis of regulatory, quality, and business risks to support informeddecision‑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 andinspectionreadiness.
• Support health authority interactions related to product changes, renewals, discontinuations, and remediation activities.
• Identifyand drive process improvements to enhance efficiency, transparency, and consistency within eligibility andrationalizationworkflows.

Qualifications

Education

• Required: Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, ora relateddiscipline.
• Preferred: Advanced degree or certification in Regulatory Affairs, Quality Systems, or Business Administration.

Experience and Skills

Required

• Experience supporting product management, regulatory, quality, or compliance activities within a medical device or lifesciencesenvironment.
• 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.
• Experience using regulatory or product lifecycle management systems.
• Effective written and verbal communication skills forcross‑functionalcollaboration.
• Strong organizational skills with the ability to manage multiple priorities and stakeholders.

Other

• Languages: Fluency in Englishrequired; Spanish strongly preferred.
• Travel: Limiteddomestic and international travel may berequired(up to ~10%).
• Certifications: Regulatory Affairs Certification (RAC) or Quality certification preferred but notrequired.

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

Johnson & Johnson 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.

Equal Opportunity Employer

Johnson & Johnson 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 & Johnson 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.

#LI-Hybrid

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

Johnson & Johnson Innovative Medicine leads in scientific advancements, developing transformative treatments with compassion to address complex diseases and improve patient lives worldwide.

Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing

Company size 10,001+ employees

Company type Privately held

Momentum

Team growth

Momentum

Team growth

5% in 12 mo

38,463 employees on LinkedIn

Feb 23 Apr 26