Quality Systems & Regulatory Compliance Specialist – Medical Devices

Consulting

Fully Remote

Full time

Alajuela Alajuela Costa Rica

Consulting

Supply Chain

City

Alajuela

Country

Costa Rica

State/Province

Alajuela

About This Role

We are seeking a highly skilled and detail-oriented professional with a strong background in quality systems management, regulatory compliance, and technical documentation within the medical device industry. The ideal candidate will have hands-on experience with FDA, ISO 13485, and MDSAP audits, and a proven track record of driving continuous improvement initiatives using Lean and Six Sigma methodologies.

What You Will Work On

• Manage and maintain quality systems in compliance with FDA, ISO 13485, and MDSAP requirements.
• Lead and support internal and external audits, including preparation, execution, and follow-up activities.
• Oversee document control and change control processes to ensure accuracy, traceability, and regulatory compliance.
• Handle product complaints and conduct thorough investigations into nonconformances (NCs) and CAPAs.
• Configure and maintain ERP systems such as SAP, JD Edwards (JDE), and Windchill for quality and documentation workflows.
• Drive continuous improvement initiatives using Lean and Six Sigma tools to enhance quality and operational efficiency.
• Lead cross-functional teams in the successful implementation of new products and global documentation harmonization projects.
• Collaborate with engineering, manufacturing, and regulatory teams to ensure alignment and compliance across all quality-related activities.
• Communicate effectively in both English and Spanish with internal teams, external partners, and regulatory bodies.
  
  

What You Will Bring

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred).
• 5+ years of experience in quality systems and regulatory compliance within the medical device industry.
• In-depth knowledge of FDA regulations, ISO 13485, and MDSAP requirements.
• Certified in Lean, Six Sigma, or equivalent continuous improvement methodologies.
• Proficient in ERP systems (SAP, JDE, Windchill) and electronic document management systems.
• Strong analytical, organizational, and communication skills.
• Demonstrated ability to lead cross-functional teams and manage complex projects.
• Bilingual proficiency in English and Spanish is required.
  
  

Preferred

• Experience with global regulatory submissions and international quality standards.
• Familiarity with risk management tools (FMEA, Fault Tree Analysis).
• Project management certification (e.g., PMP) is a plus.
  
  

What You Can Expect

• Fully remote independent contractor opportunity
• Compensation commensurate with employee qualifications, experience, and other factors including geographic location, market, and operational factors. 
• An inspirational place for you to do your best work, be engaged in meaningful ways, and continually develop the skills, competencies, and qualities that set our team apart.  
  
  

What We Do

At RGP, we're creating a future where businesses produce their best work without constraints. We've built a global network of over 2,600 experts across four regions, providing a comprehensive suite of solutions across on-demand talent, next-generation consulting, and outsourced services to support organizations at every stage of their growth journey. Trusted by Fortune 100 companies and emerging disruptors alike, we challenge conventional ways of working, drive growth, and pave the way for long-term success through bold innovation and fearless collaboration.

Our values guide everything we do and strengthen our commitment to people. By combining smart processes, human-centered design, and advanced technology, we celebrate our team's excellence and ensure we grow together. We believe in the power of continuous learning and development to drive both individual and organizational success. It’s time to rethink how work gets done. Dare to Work Differently with RGP.

RGP is proud to be an Equal Opportunity Employer and committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, national origin, gender, pregnancy, sexual orientation, gender identity, age, physical or mental disability, genetic information, veteran status, or any other legally protected trait and encourage all applicants to apply. 

Apply Now

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RGP Awards and Accolades

2022

Forbes

World's Best Management Consulting Firms

2021

Forbes

America's Best Mid-Sized Employers

Forbes

Best Management Consulting Firms

2020

Forbes

America's Best Mid-Sized Employers

Best Companies Group and Texas Monthly

Best Companies to Work For in Texas

2019

Forbes

America's Best Mid-Sized Employers

Best Companies Group and Texas Monthly

Best Companies to Work For in Texas

Netsuite

BPO Partner of the Year