Senior Process Associate, Lead Consultant, Regulatory Engineer - Milwaukee, WI
Ready to shape the future of work?
At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory , our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI , our breakthrough solutions tackle companies' most complex challenges.
If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at and on LinkedIn , X , YouTube , and Facebook .
Job Description:
Inviting applications for the role of Lead Consultant, Regulatory Engineer
Responsibilities
• Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.
Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date
Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system
Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.)
Support regulatory audits and inspections to ensure post-market surveillance compliance.
Qualifications we seek in you.
Minimum Qualifications
Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
Excellent interpersonal communication and collaboration skills
Bachelor's degree in engineering, Science or related area
Good experience working with medical devices regulations and quality management system.
proficiency with written English and with neutral English accent
Preferred Qualifications
Strong technical knowledge
Effective probing skills and analyzing / understanding skills
Strong attention to detail.
Why join Genpact?
- Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation
- Make an impact - Drive change for global enterprises and solve business challenges that matter
- Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities
- Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
- Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
Let's build tomorrow together.
The approximate annual base compensation range for this position is $65k to $80K. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant's experience, knowledge, skills, and abilities; geographic location; and internal equity
Location-based Roles - "Los Angeles, California based candidates are not eligible for this role. Milwaukee, WI area candidates are eligible for this role only."
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.