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 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,

We offer a safe and respectful workplace,

We nurture entrepreneurial spirits and empower

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

Responsibilities:

• Plan, coordinate and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.
• Author Technical file documentation to support EU MDR requirements.
• 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.
• Perform MDR gap assessments and remediation of MDD technical files.
• Provide Regulatory support to Manufacturing and R&D to perform significant change impact assessments. Participate in Change Review board to review and approve Engineering Changes.
• 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.
• Perform other related duties as assigned.

Critical Success factors :

• In-depth knowledge of medical device regulations and standards, such as FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO 14971.
• Experience in Ophthalmology or surgical instrument field preferred.
• 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:

• 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.