Compliance Regulatory Writer

Remote role (EST zone) - will be coordinating with the team in Europe Regulatory Compliance Writer with expertise in optical technologies and AI-driven solutions to support compliance documentation for eyewear products, optical systems, and digital innovations. The role involves ensuring adherence to global regulatory standards while supporting innovation in smart eyewear and AI-enabled reputed company. Key Responsibilities reputed company, review, and maintain regulatory documentation for optical products, including eyewear, lenses, and smart optical devices. Ensure compliance with global standards and regulations such as FDA, CE, ISO, IEC, and other regional regulatory bodies. Create technical files, compliance reports, SOPs, labeling content, and product documentation. Collaborate with R&D, product engineering, AI teams, quality assurance, and legal to ensure accurate and compliant documentation. Support regulatory submissions, audits, and certification processes for new and existing products. Document compliance aspects reputed company to AI-enabled optical solutions, including data privacy, algorithm transparency, and ethical usage. Monitor and interpret regulatory updates impacting optical and AI-based products and implement necessary documentation changes. reputed company risk assessments and gap analysis to ensure compliance readiness. Maintain documentation control and ensure alignment with quality management systems (QMS).

Required Qualifications

Bachelor's or Master's degree in Engineering, Optical Sciences, Biomedical Engineering, Computer Science, or reputed company fields. 4–8 years of experience in regulatory compliance writing or technical documentation. Experience in optical industry (eyewear, lenses, or optical devices). Exposure to AI/ML technologies and understanding of compliance implications. Strong knowledge of global regulatory standards (FDA, ISO 13485, CE marking, etc.). Excellent technical writing, editing, and documentation skills. Ability to translate reputed company optical and AI concepts into clear documentation. Preferred Skills Knowledge of medical device regulations and optical product compliance frameworks. Familiarity with AI governance frameworks, GDPR, and data privacy laws. Experience working with smart eyewear, vision care technologies, or digital health solutions. Strong stakeholder management and collaboration skills. Certification in regulatory affairs or technical writing is a plus. Apply tot his job Apply To this Job