6 Regulatory affairs Jobs in Bangalore (Bengaluru) | Regulatory affairs Job openings in Bangalore (Bengaluru)

20RA Lead (7–8 years) | EU MDR + India (CDSCO) | Medical Devices

Role summary

Lead regulatory strategy and submissions for a medical device portfolio (hardware + software + accessories) across the EU MDR and India (CDSCO), with strong ownership of technical documentation and lifecycle change management.

Key responsibilities

• Own regulatory strategy and submission planning for EU MDR + India; build timelines, evidence plans, and dossier readiness trackers.
• Lead/author EU MDR Technical Documentation (Annex II & III): device description, GSPR checklist, risk/benefit, V&V summaries, clinical evaluation linkage, labeling/IFU, PMS/PMCF plans.
• Drive classification and portfolio mapping; support UDI basics and EMDN/basic UDI alignment (as applicable).
• Manage Notified Body interactions: questions, responses, meeting preparation, evidence packaging, and change justifications.
• Own India lifecycle activities: CDSCO changes (PAC), license maintenance, and regulatory communications.
• Ensure regulatory alignment for standards-driven evidence: ISO 14971, IEC 62304, IEC 60601, IEC 81001-5-1, usability (IEC 62366-1), biocompatibility (ISO 10993), and sterilization/reprocessing (as applicable).
• Support labeling/claims governance: intended use, indications, contraindications, and marketing claims review.
• Build and mentor the RA team; ensure version control, traceability, and audit-ready submissions.

Must-have qualifications

• 7–8 years in regulatory affairs for medical devices (Class II/III exposure preferred).
• Strong experience with EU MDR technical documentation and handling Notified Body queries/submission packages.
• Working experience with the CDSCO regulatory lifecycle (licenses/changes) is strongly preferred.
• Solid understanding of standards-driven evidence for HW+SW devices (14971, 62304, 60601, usability, biocomp).

Nice to have

• Exposure to US FDA 510(k), clinical evaluation/PMCF, cybersecurity documentation, and SaMD claims strategy.
• Experience with complex HW+SW systems and regulated accessories/instruments.

Role & Responsibilities:

As a Business Analyst, we will require that you interact with a multitude of leaders and managers, from customers, prospects, AI suppliers, Internal stake-holders from technology and quality assurance as well as the entire research, analysis, development, delivery and support teams.

This requires maturity, empathy and an engaging personality. You must have excellent presentation and communication skills, written, spoken and creative. We seek candidates who are passionate, committed, innovative, self-driven and result focused.

Towards this end, you would be involved in the following:

• Shape new concepts and features
• Work with global QHSE leaders and AI/ML teams
• Bring your expertise and certifications into product strategy
• Engage with clients worldwide
• Support delivery teams in transforming safety performance

Ideal Candidate:

• Strong Business Analyst – HSE (Ports & Terminals) Profiles
• Must have 7+ years of experience as a Business Analyst, with 3+ years within the Ports, Container Terminals, Shipping, or Maritime industry OR with 3+ years in Health, Safety and Environment
• Must have strong domain expertise in Health, Safety & Environment (HSE / QHSE) specifically in Ports and Terminals operations
• Must have hands-on experience with HSE / QHSE software products (implementation, configuration, rollout, or functional ownership) used in Ports or Terminals
• Must have proven experience in requirements gathering, gap analysis, and writing detailed functional specifications / FRDs for enterprise or ERP-style applications
• Must have strong client-facing experience, including stakeholder interactions, UAT coordination, go-live support, and post-implementation functional support
• Must be comfortable with onsite client visits, product delivery, and training end-users on the HSE software product
• Excellent communication, presentation, and stakeholder management skills with the ability to independently own functional delivery
• Technical qualification is not mandatory; strong functional, process, and domain expertise is essential
• Experience working with ERP or large enterprise applications in Ports, Container Terminals, Logistics, or Maritime environments.
• Exposure to QHSE / Safety Management Systems, ISO standards (ISO 45001, ISO 9001, ISO 14001), or regulatory compliance frameworks.
• NEBOSH / IOSH / ISM Code or equivalent HSE certifications.

Job Title : Information Management (IM) Advisor – Data Controller

Job Overview :

The IM Advisor (Data Controller) will serve as the primary liaison between business and IT, ensuring best practices in Information Management (IM) solutions, compliance, and data governance.

This role involves designing and delivering IM solutions, ensuring compliance with IM standards, and driving awareness within the organization.

Key Responsibilities :

• Act as the first point of contact for Information Management, advising business teams on best practices and compliance.
• Implement and maintain control systems, procedures, and data validation processes for engineering data warehouses (EDW).
• Collaborate with contractors to ensure data consistency, validation, and integration into central repositories.
• Drive compliance with IM standards, data privacy regulations, and other legal requirements.
• Monitor and improve IM processes, ensuring efficient data handover and control mechanisms.
• Develop and manage data control procedures for projects, ensuring seamless transition to operations.
• Provide IM training to end users and manage offshore data support services.

Key Skills & Qualifications :

• Experience : 3-10 Years in data control on major capital projects, with EPC interface management.
• Technical Expertise :
• Engineering databases, SharePoint, and document management systems.
• Experience with Engineering Data Warehouses (SPF, AVEVA, AIM, ALIM).
• Reporting tools (Power BI, Tableau).
• Knowledge of engineering IM scope, data modeling, and maintenance processes.
• Compliance & Governance : Knowledge of GDPR, security, privacy, and IM best practices.
• Leadership & Communication : Strong interpersonal skills, global stakeholder engagement, and ability to manage multiple projects.
• Technology Awareness : Familiarity with RPA, AI, Blockchain, and machine learning in IM processes.

Preferred Qualifications:

• Previous experience with Shell or similar organizations.
• Knowledge of Agile methodologies and Continuous Improvement practices.

Job Title: QA Associate 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

3-5 years of relevant experience in Medical Devices Industry.

Area of Expertise:

• To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
• Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
• Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
• Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
• Manage all documentation related to internal and external audit.
• Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
• Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
• Co-ordination of Management Review Meetings & its action items implementation

Experience Required:

• 3-5 years of relevant experience in Medical Devices Industry.
• Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
• Ability to read and understand standard requirements independently.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
• Good understanding of design control, and post marketing processes
• Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
• Working knowledge of an e-QMS is an added advantage.

• Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
• Support in ensuring transition activity is planned and executed to schedule, budget and scope
• Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
• Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
• Keep stakeholders involved in transition process and update them with the progress and roadblocks
• Promote awareness of transition planning and support processes within the GCC
• Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
• Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC

Skills:

• Proven knowledge of service transition methodology, tools and templates through experience or qualifications
• The ability to identify, escalate and manage project risks with the Transition Lead
• 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
• Good exposure in previous roles to multi-cultural, transversal functions
• Pharma background with experience across the systems development life cycle with experience in different project phases
• Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing