Specialist - Regulatory Affairs - Operations 4A

Specialist - Regulatory Affairs - Operations

Ready to turn bold ideas into real-world impact?
 At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
 
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment. 
 
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
 Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description

D  Complaints Management

The Complaints Analyst is responsible for reviewing complaint records. This role performs detailed complaint assessments, completes missing documentation, supports investigations, and ensures complaint files are accurate, complete, and audit ready. The analyst works closely with Quality, Regulatory Affairs, and subject matter experts to resolve gaps and maintain project timelines. In addition, the role documents all activities and supports the preparation of metrics and reports for management and regulatory review. 

Day to Day Responsibilities:

• Review complaint records

• Assess complaint files for missing documentation, approvals, or required actions.

• Complete and document activities in ETQ.

• Support the completion of missed investigations and follow-up activities.

• Complete decision trees for MDR reporting to determine reportability for US and EMEA and APAC

• Complete Medwatch forms and submit to aligned Health Authoritis

• Gather and attach supporting documentation to complaint files.

• Ensure complaint records comply with SOPs and regulatory requirements.

• Coordinate with Quality, Regulatory Affairs, and product SMEs to resolve questions.

• Document findings and actions in project tracking tools.

• Escalate potential patient safety or regulatory concerns to management.

• Participate in team calibration sessions to ensure consistency across reviewers.

• Meet daily and weekly to review productivity and quality targets.

• Maintain complete and audit-ready documentation for all activities.

• Provide status updates and support the preparation of project metrics and reports.

KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE

• Associate degree in science or related field of study

• Related experience within the pharmaceutical industry. Will consider an

advanced degree in lieu of years of experience.

• Strong Verbal and Written Communication Skills in English

• Problem Solving Skills

• Adept at Attention to Detail

• Strong understanding of Good Documentation Practices

• Good organizational skills

• Analytical skills

• Self-motivated/directed

• Computer literate—proficient in use of word processors. Must be able to

understand and utilize complaint database software and reporting tools.

• Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical

devices, combination products and biologics

• Project and Time Management Skills

• Interpersonal skills-must be proactive, personable, flexible, team-oriented

• Customer Service Skills

• Ability to multitask in a highly stressful environment

• Ability to operate in a constantly changing environment

Qualifications

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs

Certifications

Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills

Client Relations, Collaboration Tools, Data Analytics, Generative AI, Lean Six Sigma (LSS), People Leadership, Personal Effectiveness, Storytelling

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Hybrid

Work Shift -

Day Job (Costa Rica)

Why join Genpact?
•    Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
•    Make an impact – Help global enterprises solve business challenges that matter 
•    Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
•    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 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.  
Let’s build tomorrow together. 
 
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.