Regulatory Affairs Associate

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 Regulatory Affairs Associate is an integral part of the Quality and Regulatory team. The associate will be responsible for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analysing data, reporting trends, and coordinating CAPA facilitation. In addition, the associate will provide regulatory support to product development, quality, and production with respect to design, process, and quality concerns.

Responsibilities:

• Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in ASEAN, Middle East and GCC Nations.
• Co-ordinates with distributors for Medical Device registration in other parts of the world as and when required.
• Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.
• Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies.
• Provides regulatory information and guidance for proposed product claims/labelling.
• Identifies the need for new regulatory procedures, Operating Procedures, and participates in development and implementation.
• Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
• Assists other departments in the development of Operating Procedures to ensure regulatory compliance.
• Reviews proposed product changes for impact on regulatory status of the product.
• Prepare/record changes to controlled documents including formatting, review and confirm changes with relevant departments, prepare training material, and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective.
• Performs other duties that are reasonably assigned.

Critical Success factors:

• Identify most favorable regulatory routes and pathways to ensure faster and cost-effective registrations.
• Excellent written and verbal communication skills, and able to effectively manage regulatory authority or auditor’s intent.
• Complies with regulatory requirements of the ASEAN, Middle East and GCC Nations and any other regulations of target markets.
• Be aware of recent and future regulatory trends and plan accordingly to ensure Volk’s compliance.
• Ability to develop and evaluate risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets.
• Must show appropriate judgement and logic to show improvements to the quality system, document control, and regulatory compliance.

Qualifications:

• A Bachelor's degree is required, preferably in Science, Engineering, or Business.

Experience:

• Minimum 3 years of experience.
• Comprehensive understanding of applicable regulations of ASEAN, Middle East and GCC Nations.