Lead Regulatory Affairs

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology. For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

Why join us?

We are a Great Place to Work® certified organisation,

with an employee centric culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.

We offer a safe and respectful workplace,

where everyone can be who they ‘REALLY’ are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower

them to think beyond the possibilities, to discover, shape and build their own unique stories. We promote and support non-linear career growth for the right talent.

We are simple, humble and approachable, and we believe in leadership

at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us!

Position Objective: The Lead Regulatory Affairs will be responsible for creation, implementation and maintenance of the world-wide regulatory requirements for Class I and Class II sterile and reusable medical devices in compliance to FDA 21 CFR, ISO 13485, and EU MDR 2017/745. The Lead Regulatory Affairs position contributes to clinical evaluation reporting deliverables including clinical evaluation plans and reports (CEP/CER), and post-marketing compliance related documentation required to support MST medical device EU MDR registrations. Provides knowledge and support to the company and other regulatory personnel to enable company to operate within regulatory guidelines.

Responsibilities: Responsible for generating scientific research to support the clinical evidence requirements for EU, US, and other OUS regions. Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions. Plan, prepare, and finalize regulatory documents focused on global clinical and post-market surveillance requirements, particularly EU and US; these include, but are not limited to, clinical evaluation plans and reports, clinical development plans, post-market surveillance plans, periodic safety updates (PSUR), summary of safety and clinical performance (SSCP), post-market clinical follow-up plans and reports (PMCF), and trend reports. Works closely with internal resources to ensure clinical evidence is aligned with risk management reports, user requirements, post-production surveillance, product labelling and claims, etc. Establish document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements. Lead cross-functional document planning and review through collaboration with colleagues across departments. Stay updated with regulatory guidelines, industry trends, and best practices in regulatory medical writing. Coach more junior writers on document and process planning and content. Provide regulatory support and subject matter expertise as needed during audits or inspections related to clinical evidence documents and processes. As assigned, plan, coordinate and prepare document packages for regulatory submissions, including FDA 510(k), EU Technical Files, Japanese Todokede/Ninsho Documents, Canadian Device License Applications and other license and registration documents. Provides support as needed for non-project related “regulatory excellence” activities. Ensures timely, clear communications to internal stakeholders of project status and concerns. Perform other related duties as assigned.

Critical Success factors: Working knowledge of FDA QSR, ISO 13485, and EU Medical Device Directive (93/42/EEC), EU Medical Device Regulations (2017/745), MDSAP, and other international regulations. Experience in post-market surveillance, clinical evaluation plans and reports, clinical development plans, post-market surveillance plans, periodic safety updates (PSUR), summary of safety and clinical performance (SSCP), post-market clinical follow-up plans, reports (PMCF), and trend reports, or regulatory affairs is highly desirable. Familiarity with documentation and submission requirements for regulatory bodies is an advantage.

Key attributes: Thorough understanding of clinical research and regulatory requirements. Familiarity with medical terminology and clinical data analysis. Demonstrated ability to interpret, summarize, and present clinical, scientific, and statistical information in complex documents to ensure accuracy and clarity of content. Authoring experience with CER’s, post-market surveillance plans, PSUR’s, SSCP’s, and/or similar documents.

Qualifications: BS/BA in a science/engineering discipline or an equivalent technical field; or a minimum 5-year relevant experience. B/S or M/S degree in Microbiology or related field is a plus to support special projects.

Experience: 5-10 years of relevant scientific or medical device technical experience. 2-4 years relevant medical writing experience. Experience in ophthalmology or surgical instruments field a plus. Strong knowledge of FDA and EU MDR regulations and post-market requirements as defined in 21 CFR 814.82 Subpart E and Chapter VII of Regulation EU 2017/745 (MDR) RA/QA certifications a plus.