Regulatory Affairs Intern

at  Optos

MINIMUM QUALIFICATIONS

• Degree (or equivalent) in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
• Excellent practical experience of regulatory submissions and requirements.
• Widespread experience in the highly regulated medical device market.
• Good awareness of FDA & MHRA systems and procedures.
• Previous Knowledge of ISO 9001/13485 system is essential.
• Knowledge of cGMP / Quality System Regulations is essential.
• Direct experience with Medical Device approvals, specifically with clinical trial requirements.
• Excellent presentation skills are required.
• Good computer skills (MS Office applications).
• Experience in Clinical Trials of Medical Devices.

ROLE SUMMARY

We are currently looking for a Regulatory Affairs Intern to join our Regulatory team based in Dunfermline on a 3-month fixed term contract. You will be responsible for assisting with the implementation and monitoring of a new regulatory intelligence process to assure that Optos meets global regulatory compliance requirements. You will assist with and assure that Optos implements, complies with, and maintains state of the art processes regarding regulations such as Data Protection, Financial Restrictions, Export Controls and Medical Device Regulations. You will also support the team with the Net Zero plan and activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Keeping the business up to date with the latest developments in global regulations.
• Monitor regulatory intelligence software for the latest updates on regulations & guidance such as Medtech, data security, environmental & waste, packaging, cybersecurity and AI.
• Assure compliance to GDPR, HIPAA, Sunshine Act, ICP and other regulations.
• Responsible for supporting next zero activities in line with the project plan.
• Accurate maintenance and clear communications of all regulatory issues pertaining to the product compliance, regulatory compliance and adverse issues.
• Monitoring of compliance metrics and maintaining the electronic system/data that generates them.
• Provide regulatory assistance in the development and registration of Optos products.
• Communicate effectively with external and internal parties, building strong relationships.
• Assist SME to project teams, other departments and key stakeholders to ensure key stakeholders and customers are kept informed on regulations issues which impact their roles and deliverables
• Perform timely and accurate data entry of regulatory documents and maintenance of Country/Product information in the appropriate management system.