Are you passionate about regulatory affairs in the medical device industry? Halma plc, a global leader in life-saving technology, is hiring a Regulatory Affairs Executive in Bengaluru, Karnataka. Join an FTSE 100 company renowned for its innovative solutions, employee-centric culture, and sustainable growth. This role offers a unique opportunity to contribute to cutting-edge medical device compliance, ensuring safety and quality worldwide. If youโre seeking a career in regulatory affairs with a company that values autonomy, trust, and work-life balance, apply today!
Job Responsibilities
As a Regulatory Affairs Executive at Halma plc, you will play a critical role in ensuring compliance with global medical device regulations. Your responsibilities include:
- Planning and Preparing Regulatory Submissions: Coordinate and create document packages for submissions and renewals, focusing on EU Technical Files, MDSAP, and other regulated markets.
- MDR Gap Assessments: Conduct assessments and remediation of MDD technical files to ensure compliance with Regulation (EU) 2017/745.
- Authoring Procedures and Templates: Develop and maintain regulatory department procedures and templates.
- Maintaining Registrations: Manage annual facility registrations, device listings, GSI, and GUDID as required by the US FDA.
- Monitoring Regulations: Stay updated on standards and regulations applicable to Lamidey Noury Medicalโs devices and conduct impact analyses of amendments.
- Export Registration Management: Prepare and manage export registration files, responding to distributor and authority requests.
- Collaboration with Teams: Work closely with the export sales team to prioritize registrations and manage quality contracts.
- FDA Communications: Handle 510K files and communications with the FDA.
- Additional Duties: Perform other related tasks as assigned to support regulatory compliance.
Qualifications and Skills
To excel in this role, candidates should meet the following qualifications:
- Education: Masterโs degree in Regulatory Affairs, Science, or equivalent.
- Experience: 3-5 years of experience in quality assurance or a regulated industry, preferably in medical device regulatory affairs.
- Regulatory Knowledge: Familiarity with Regulation (EU) 2017/745, FDA requirements (510K, CFR 21 Part 820), SFDA, and MDSAP.
- Skills:
- Strong analytical and problem-solving skills to address complex technical issues.
- Excellent communication and collaboration skills for cross-functional teamwork.
- Detail-oriented and organized, with the ability to manage multiple priorities.
- Familiarity with regulatory documentation and submission processes is a plus.
Why Join Halma plc?
Halma plc offers a dynamic and inclusive workplace certified as a Great Place to Workยฎ. Hereโs why this role stands out:
- Employee-Centric Culture: Experience autonomy, trust, respect, and work-life balance in a supportive environment.
- Career Growth: Non-linear career paths and opportunities to shape your own story with a global leader.
- Impactful Work: Contribute to life-saving medical device technologies that make a difference worldwide.
- Diverse and Inclusive: Bring your authentic self to work, leveraging your unique talents and expertise.
- Sustainable Growth: Join a company with a 42-year track record of โฅ5% annual dividend growth, unmatched in the FTSE 100.
How to Apply
Ready to join Halma plcโs mission to save lives through technology? Submit your application via the Pharmabharat.com job portal or directly through Halmaโs career page at Halma.com. Include your updated CV, a cover letter highlighting your regulatory affairs experience, and any relevant certifications. Applications are reviewed on a rolling basis, so apply by November 24, 2025, to be considered.
FAQs
Q: What is the work environment like at Halma plc? A: Halma fosters an inclusive, supportive culture with a focus on autonomy, trust, and work-life balance. Employees are empowered to innovate and grow in a collaborative setting.
Q: What qualifications are most important for this role? A: A masterโs degree in regulatory affairs or science, 3-5 years of experience in a regulated industry, and knowledge of EU and FDA regulations are critical for success.