At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Manatí, Puerto Rico, United States, San Lorenzo, Puerto Rico, United States

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Compliance Specialist to be in Manatí, Puerto Rico.

The Senior Regulatory Compliance Specialist is responsible for maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements.

You will be responsible for:

• Support execution and management of external audit readiness activities to ensure site readiness at all times. These activities include audit logistics, front room/back-room arrangements, identifying/preparing SME’s, etc.
• Support management of external audits: e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, JJRC or ERC Audits of the site.
• As required, assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site.
• Support mock external audits/inspections as part of External Audit Readiness activities.
• Provide timely information to support the external audit/inspection process.
• Ensure external audit metrics are reported and published. Drive compliance an improvement in metric targets.
• Execute internal audits according to the established internal audit procedures.
• Ensure timely and adequate responses to internal audit observations, including failure investigations, root cause analysis and correction/corrective/preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
• Ensure internal audit metrics are reported and published. Drive compliance and improvement in metric targets.
• Support the effective deployment of J&J Quality System standards at the site.
• Connect and collaborate with the compliance teams of other sites and regions.
• Ensure that internal and external audit metrics are consistently and accurately captured, and that they are reported and published at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain).
• Drive compliance and improvements in metric targets.
• Create reports and communicate performance against metrics to key stakeholders.
• Communicate adverse trends in metrics and take risk-based action to remediate.

Qualifications

Education:

• A minimum of a Bachelor’s of Science Degree is required.

Experience and skills

Required:

• A minimum of four (4) years of experience in the FDA/ISO/Health Authority regulated industry (medical devices or pharmaceutical).

Preferred:

• Experience in Quality, Manufacturing or Engineering roles
• Auditing experience
• Experience leading or managing an internal audit program
• Experience in supervisor position
• Knowledge of FDA/ISO/Health Authority Quality System regulations and standards
• Computer literate. Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is
• required. Experience with Microsoft Project
• Experience in leading and managing projects and milestones
• Experience with Minitab

Other:

• Training in Process Excellence/Six Sigma tools and methodologies and Certification is preferred.
• Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification highly preferred.
• Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.
• This position may require up to a 10% of domestic travel.
• This position will be based in Manatí, PR and will also provide support to San Lorenzo, PR and Guaynabo, PR sites.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.