Regulatory Compliance Specialist
14 hours ago
About Halma plc:
Halma is a leading global life-saving technology group, driven by a clear purpose to improve safety and quality of life for people around the world.
As an FTSE 100 company with headquarters in the UK and operations in over 20 countries, including regional hubs in India, China, Brazil, and the US, we offer a unique opportunity to work in a dynamic, diverse environment.
We are home to nearly 50 specialist companies that push the boundaries of science and technology, delivering innovative solutions to real-world problems.
Our history of sustained growth has resulted in record long-term revenues and profits, with 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 certified Great Place to Work organisation, with a culture anchored on autonomy, trust, respect, humility, work-life balance, team spirit, and approachable leadership.
At Halma plc, we value our employees' unique talents, knowledge, expertise, experiences, and backgrounds, and empower them to create meaningful outcomes.
We believe in nurturing entrepreneurial spirits, thinking beyond possibilities, discovering, shaping, and building individual stories. Non-linear career growth is promoted for talented individuals.
We lead from all levels, embracing simplicity, humility, and approachability. Our purpose is brought to life through inclusive leadership, where everyone makes an impact.
Position Overview:
The Regulatory Affairs Associate plays a pivotal role within the Quality and Regulatory team. Key responsibilities include maintaining regulatory compliance via registrations, document control, participating in internal and external audits, analysing data, reporting trends, and coordinating CAPA facilitation. Additionally, this role provides regulatory support to product development, quality, and production regarding design, process, and quality concerns.
Key Responsibilities:
- Communicates effectively with regulatory authorities and distributors to prepare and submit documentation for marketing approval in ASEAN, Middle East, and GCC Nations.
- Collaborates with distributors for Medical Device registration in other regions as required.
- Conducts research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to regulatory registrations and submissions.
- Authors, reviews, and publishes paper and electronic submissions, communicating with regulatory authorities and government agencies.
- Provides regulatory guidance and information for proposed product claims/labelling.
- Identifies new regulatory procedures, Operating Procedures, and participates in their development and implementation.
- Trains stakeholders on current and new quality and regulatory requirements, ensuring organisational compliance.
- Assists other departments in developing Operating Procedures to ensure regulatory compliance.
- Reviews proposed product changes for impact on regulatory status.
- Prepares/records changes to controlled documents, formatting, review, confirms changes with relevant departments, prepares training material, and coordinates user acceptance to ensure electronic document processing is complete and document control is maintained.
- Performs additional duties reasonably assigned.
Critical Success Factors:
- Identify the most favorable regulatory routes and pathways to achieve faster and cost-effective registrations.
- Demonstrate excellent written and verbal communication skills, effectively managing regulatory authority or auditor's intent.
- Comply with regulatory requirements of ASEAN, Middle East, and GCC Nations, as well as other target market regulations.
- Stay aware of recent and future regulatory trends, planning accordingly to ensure Halma's compliance.
- Develop and evaluate risk of potential regulatory strategies for new and modified products by conducting research and analysis in both new and sustaining markets.
- Demonstrate appropriate judgement and logic to suggest improvements to the quality system, document control, and regulatory compliance.
Qualifications and Experience:
- A Bachelor's degree is required, preferably in Science, Engineering, or Business.
- Minimum 3 years of experience.
- Comprehensive understanding of applicable regulations of ASEAN, Middle East, and GCC Nations.
Estimated Salary: £45,000 - £55,000 per annum
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