Job Description

Purpose

Building an AI‑first organisation is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function—to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve , must drive an AI first sense of purpose and urgency.

The Senior Regulatory Affairs Analyst is responsible for supporting Clinisys' global regulatory affairs activities to ensure ongoing compliance with applicable healthcare, medical device, software, diagnostics, and regulatory requirements across all markets in which Clinisys operates. This role serves as a key contributor to regulatory strategy, product registrations, submissions, regulatory assessments, compliance monitoring, and regulatory intelligence activities, ensuring that products remain compliant throughout their lifecycle.

This position partners closely with Regulatory Affairs, Quality, Clinical Safety, Product Management, R&D, Operations, Legal, and Customer-facing teams to support regulatory approvals, market access, change management, and continued compliance activities. The role provides expertise in interpreting and applying global regulatory requirements and supports business initiatives through proactive regulatory guidance.

This role requires strong regulatory knowledge, analytical skills, attention to detail, and the ability to manage multiple priorities while working effectively within a global matrix environment.

This role is based in Bangalore, India with a requirement to be on-site 3 days per week.

Essential Functions

• Prepare, compile, review, and maintain regulatory submissions, registrations, notifications, and renewals with applicable regulatory authorities.

• Manage and maintain product registrations and regulatory records across federal, state, and international regulatory agencies.

• Assess the regulatory impact of product changes, software releases, design modifications, labeling updates, and new functionality.

• Monitor global regulatory requirements and emerging regulations, standards, and guidance documents affecting Clinisys products and services.

• Conduct regulatory assessments to support product development, market expansion, acquisitions, and strategic business initiatives.

• Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into product design, development, verification, validation, and post-market activities.

• Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks.

• Author and maintain regulatory documentation including technical documentation, declarations, regulatory assessments, intended use statements, labeling reviews, and compliance records.

• Support responses to regulatory authority inquiries, customer regulatory requests, audits, inspections, and compliance assessments.

• Participate in regulatory review of complaints, CAPAs, risk management documentation, post-market surveillance activities, and field actions as required.

• Provide regulatory guidance regarding classification, registration, market access, and product lifecycle management activities.

• Support regulatory due diligence activities associated with partnerships, acquisitions, and third-party products.

• Utilize AI-enabled tools and analytics to monitor regulatory changes, identify compliance trends, and improve regulatory process efficiency.

• Develop and maintain regulatory intelligence reports and communicate relevant regulatory changes to stakeholders.

• Support continuous improvement initiatives related to regulatory affairs processes, documentation, lifecycle management, and compliance management activities.

Skills Needed to Be Successful

• Strong knowledge of global software as a medical device, medical device, healthcare software, diagnostics, and life sciences regulatory frameworks.

• Knowledge of FDA, EU MDR, IVDR, UK MDR, Health Canada, and other international regulatory requirements.

• Ability to interpret and apply regulations, standards, guidance documents, and regulatory policies to business and product activities.

• Great ability to work within a matrix environment with multiple stakeholders.

• Experience preparing and maintaining regulatory submissions, registrations, certifications, and technical documentation.

• Strong analytical and critical-thinking skills with the ability to assess regulatory impact and compliance risks.

• Ability to evaluate complex technical information and translate regulatory requirements into practical business guidance.

• Experience conducting regulatory assessments and supporting regulatory decision-making.

• Familiarity with regulatory intelligence tools, databases, and monitoring processes.

• Experience utilizing AI-enabled tools and digital technologies to support regulatory research, monitoring, and compliance activities.

• Strong organizational skills with the ability to manage multiple projects, deadlines, and priorities simultaneously.

• Excellent written and verbal communication skills.

• Effective collaboration and stakeholder management skills across global teams.

• High attention to detail and accuracy in regulatory documentation and records management.

• Knowledge of software development lifecycle processes and regulated software environments preferred.

• LIMS/LIS industry experience preferred.

Required Experience & Education

• Bachelor's degree in Regulatory Affairs, Science, Engineering, Life Sciences, Healthcare, Information Technology, Business, or a related field.

• 5-8 years of experience in Regulatory Affairs within a regulated industry (medical device, diagnostics, software as a medical device, healthcare software, or life sciences preferred).

• Experience preparing, supporting, or managing regulatory submissions, registrations, certifications, and market access activities.

• Experience supporting regulatory compliance throughout the product lifecycle, including development, commercialization, change management, and post-market activities.

• Demonstrated experience interpreting and applying global regulatory requirements.

• Experience supporting interactions with regulatory agencies, notified bodies, customers, auditors, and certification bodies.

• Strong knowledge and practical application of, but not limited to: FDA 21 CFR Part 820/QMSR, EU MDR, IVDR, UK Medical Device Regulations, ISO 13485, ISO 14971, IEC 62304, DCB0129/DCB0160, and applicable international regulatory requirements.

• Experience with software medical devices, healthcare software, laboratory systems, diagnostics, or digital health technologies preferred.

• Regulatory Affairs Certification (RAC) or equivalent professional certification preferred.

• Experience supporting global organizations and products across multiple international markets preferred.

• Master's degree in Regulatory Affairs, Life Sciences, Engineering, or related discipline preferred.

Supervisory Responsibilities

· None

Physical Requirements

· Work is performed in a normal office setting with minimal exposure to health or safety hazards. Prolonged periods of sitting at a desk and working on a computer.

· Travel may be required

· Moderate lifting/carrying 15-44 lbs.; use of fingers; walking/standing 2-6 hours

· Travel to client sites that can pose risk associated with healthcare organization

· May be required to follow customer location health and safety requirements

Benefits

Our benefits for Full Time employees are designed to help you move forward in your career, and in areas of your life outside of work. From health and wellness benefits, 401 (k) Savings Plan, stock incentive programs, paid time off, parental leave, and tuition assistance, we've got you covered with our total rewards package.

Clinisys’s Commitment to Equal Opportunity

Clinisys Information systems is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.

General Guidance:

This job description is meant to provide an accurate depiction of tasks and accountabilities that are most often associated with this role. While we strive to provide an accurate depiction, nothing in this description restricts the company from changing, reassigning, expanding or reducing scope of accountabilities and is subject to change at any time.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.