Halma plc, a globally renowned life-saving technology company, is seeking a Regulatory Affairs Associate for their team in Bengaluru, Karnataka. This position offers a unique opportunity to contribute to impactful work while thriving in an employee-centric culture.
About Halma plc
Halma plc is a FTSE 100 company headquartered in the UK, operating across 23 countries with regional hubs in India, China, Brazil, and the US. The company comprises nearly 50 global subsidiaries specializing in cutting-edge technologies that drive innovation in science and technology.
Halma is dedicated to its purpose of safeguarding lives and promoting sustainability. Recognized as a Great Place to Work®, the company values autonomy, trust, respect, and work-life balance. Employees enjoy leadership opportunities, non-linear career growth, and a workplace where individuality is celebrated.
Job Responsibilities
As a Regulatory Affairs Associate, your role will involve:
- Documentation and Submissions: Preparing and submitting regulatory documents for marketing approvals in ASEAN, Middle East, and GCC Nations.
- Collaboration: Coordinating with distributors for medical device registration globally.
- Data Management: Tracking, retrieving, and distributing documents related to regulatory registrations.
- Regulatory Compliance: Authoring, reviewing, and publishing submissions; providing guidance on product claims and labeling.
- Process Improvement: Identifying and implementing new regulatory procedures and operating practices.
- Training and Support: Educating stakeholders on regulatory requirements and assisting departments in developing compliant operating procedures.
- Product Review: Evaluating product changes for regulatory implications.
- Document Control: Managing controlled documents, coordinating changes, and maintaining document processing standards.
- Auditing and CAPA: Participating in internal and external audits and facilitating Corrective and Preventive Actions (CAPA).
Qualifications
To excel in this role, the following qualifications are required:
- Education: A Bachelor’s degree in Science, Engineering, or Business.
- Experience: Minimum of 3 years in regulatory affairs.
- Regulatory Knowledge: Comprehensive understanding of regulations in ASEAN, Middle East, and GCC Nations.
Key Skills
- Strong written and verbal communication abilities.
- Familiarity with quality systems, document control, and regulatory compliance.
- Capability to evaluate and mitigate risks for regulatory strategies.
- Awareness of current and future regulatory trends.
- Analytical and decision-making skills for improving compliance and operational processes.
