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Regulatory Compliance Executive

3 weeks ago

Bengaluru, Karnataka, India Halma plc Full time
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.

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 promote and support non-linear career growth for the right talent.

Plan, coordinate and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.

Review product labelling (advertising, promotions, IFUs, claims, device labelling) for regulatory compliance.

Contribute to complaint handling process and prepare/submit MDRs and Incidents to appropriate health authorities.

Provide Regulatory support to Manufacturing and R&D to perform significant change impact assessments. Develop and maintain Regulatory Information Management system.

Co-author regulatory plans for new product introduction or product line extensions.

Author Regulatory department procedures, templates.

Provide guidance, training, and direction on regulatory topics to Microsurgical Technology teammates.

Maintain annual facility registrations, device listing, GSI, and GUDID as required by US FDA.

In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO

Experience in Ophthalmology or surgical instrument field preferred.

Experience in medical device development, quality assurance, or regulatory affairs is highly desirable.

Familiarity with documentation and submission requirements for regulatory bodies is an advantage.

BS/BA in Engineering, Life Sciences, or an equivalent technical field.

MS in Regulatory Affairs or RA/QA certifications a plus.

Experience:

~5-8 years of experience in Quality or a regulated industry is preferred.