Regulatory Affairs Executive

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 specialize 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 organization, 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!

Responsibilities :

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

Perform MDR gap assessments and remediation of MDD technical files.

Author Regulatory department procedures, templates.

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

Carry out monitoring regulations and standards applicable to Lamidey Noury Medical's medical devices.

Conduct impact analysis of amendments to standards and regulations applicable to Lamidey Noury Medical's medical devices.

Manage the submission of export registration files by providing the information requested by distributors and / or authorities.

Respond to requests from distributors and / or authorities to follow up on the submission of files.

Maintain registrations by managing file renewals.

Follow registration certificates and quality contracts with distributors.

Collaborate with the export sales team to monitor registrations and prioritize them

Manage 510K files and communications with the FDA.

Perform other related duties as assigned.

Critical Success factors :

Have significant experience in regulatory affairs applied to medical devices

Have knowledge of standards, regulations, and legal requirements applicable to medical devices : Regulation (EU) 2017 / 745, FDA requirements (510K, CFR 21 part 820), SFDA, MDSAP.

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

Strong analytical and problem-solving skills with the ability to assess complex technical issues.

Excellent communication and collaboration skills to work effectively with cross-functional teams.

Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously.

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

Qualifications :

You have a master's degree in regulatory affairs, science, or equivalent

Experience :

3-5 years of experience in Quality or a regulated industry is preferred.