Ra Executive

Job Summary:

The Regulatory Affairs Executive will be responsible for ensuring that the company's

precision optical products comply with all relevant regulatory standards and requirements in

domestic and international markets. This role involves preparing and submitting regulatory

documentation, maintaining compliance with industry standards (e.g., ISO, FDA, CE), and

supporting product development teams with regulatory guidance throughout the product

lifecycle.

Key Responsibilities:

• Prepare, review, and submit regulatory documentation (e.g., technical files,declarations of conformity, 510(k), CE marking dossiers).
• Ensure ongoing compliance with applicable international regulations (FDA, EUMDR/IVDR, ISO 13485, RoHS, REACH, etc.).
• Liaise with certification bodies, regulatory agencies, and internal stakeholders toensure timely product approvals.
• Maintain product registrations and support international market access.
• Monitor changes in regulatory requirements and assess their impact on companyproducts and processes.
• Participate in internal and external audits; assist in corrective/preventive actions asneeded.
• Collaborate with R&D, Quality, and Manufacturing teams to support regulatorystrategies for new product development and changes to existing products.
• Manage and maintain regulatory documentation databases and records.
• Conduct regulatory risk assessments for materials, components, and productchanges.
• Support labeling, packaging, and marketing material reviews for regulatorycompliance.

Qualifications & Requirements:

• Bachelor degree in Life Sciences, Engineering, Physics, Regulatory Affairs, or a related field.
• 2to5 years of experience in Regulatory Affairs, preferably in optics, medical devices,or high-precision manufacturing industries.(Optional)

• Knowledge of relevant regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU

MDR, CE marking, ITAR if applicable).

• Strong understanding of technical documentation, product lifecycle, and quality

systems.

• Attention to detail and strong organizational and communication skills.

• Ability to manage multiple projects in a deadline-driven environment.

• Proficiency in Microsoft Office and document control systems.

Preferred Experience:

• Experience with Class I/II medical devices involving optical components.

• Familiarity with cleanroom production or controlled manufacturing environments.

• Understanding of optical specifications (e.g., ISO 10110) and metrology

requirements.

Working Conditions:

• Primarily office-based with occasional visits to production, lab, or cleanroom

environments.

• May involve interaction with global regulatory agencies and clients.