Regulatory Affairs Jobs: Cyient is Hiring a Regulatory Engineer | Apply Now
If you’re searching for high-impact Regulatory Affairs jobs in the medical device sector, this opportunity at Cyient offers the perfect blend of innovation, compliance, and career growth. As a key player in shaping global healthcare safety standards, Cyient is now hiring a Regulatory Engineer an exciting role designed for professionals looking for Life Science Jobs, ready to elevate their careers and work on global regulatory frameworks.
Job Details:
- Job Title: Regulatory Engineer
- Location: Bengaluru, India
About the Company:
Cyient is a globally recognized consulting-led, industry-focused technology solutions company that partners with leading organizations across aerospace, medical technology, telecommunications, energy, and manufacturing. With more than three decades of innovation and engineering excellence, Cyient is known for delivering high-quality digital, product, and operational solutions that drive transformation and growth worldwide.
For professionals seeking impactful Regulatory Affairs jobs or growth-driven life science jobs, Cyient stands out as a destination where technology, compliance, and healthcare innovation intersect. The company supports global medical device manufacturers by offering end-to-end regulatory, quality, and engineering services—making it a powerful ecosystem for professionals specializing in medical device standards, compliance, SaMD, and global regulatory frameworks.
A Cyient career empowers employees to work on cutting-edge regulatory projects, collaborate with multinational teams, and contribute directly to the safety and effectiveness of healthcare technologies used worldwide. With a strong culture of learning, inclusivity, and technical excellence, Cyient provides the ideal environment for regulatory engineers, biomedical professionals, and compliance specialists to thrive and make measurable impact.
Key Responsibilities:
- Prepare CDRs and TRFs aligned with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation, EU-MDR 2017/745, UKCA, Canadian and Australian regulatory requirements
- Conduct gap assessments to identify compliance risks and improvement opportunities
- Develop remediation plans including DHF, technical files, risk management, labeling, usability documentation
- Analyze design change records and manage regulatory compliance checklists
- Work cross-functionally with engineering, product, quality, and clinical teams
- Update internal processes based on new regional/global regulatory changes
- Support internal audits and external audit readiness
- Liaise with regulatory bodies for submissions and product registrations
Educational Requirements:
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or related fields
- Advanced certifications (e.g., RAC, ISO 13485 Lead Auditor) are an advantage
Experience:
- Minimum 3–5 years of professional experience in regulatory affairs, quality assurance, or compliance for medical devices; at least 1–2 years focused on Software as a Medical Device (SaMD) or medical device software.
- Hands-on experience preparing technical documentation, gap assessments, and compliance reports for the EU, US, and other key markets.
- Practical knowledge of the cited standards (IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417), and global device regulations (EU-MDR, UKCA, Canadian, and Australian frameworks).
- Experience in change management, risk assessment, and nonconformance remediation in a regulated environment.
- Strong organizational, documentation, and cross-functional communication skills.
- Familiarity with electronic QMS and regulatory document management platforms is advantageous.
Skills Required:
- Quality Standards
- Deliverables Management
- IEC 62304
- Medical Devices
- Management Review
- Regulatory documentation
- Risk assessment & change management
- Strong analytical & communication skills
This role is a standout opportunity for professionals aiming to grow in Regulatory Affairs jobs while contributing to global medical device safety. With Cyient’s innovation-driven culture and strong industry footprint, this position provides the perfect platform to elevate your life science career. If you’re ready for impactful work, global exposure, and a thriving professional journey, this is your moment to apply and move your Cyient career forward.
