Regulatory Affairs Consultants

Regulatory Strategy and Compliance:

 

• Develop and implement regulatory strategies to support product development and market access.

• Ensure that all medical devices comply with regulations in each intended market (e.g., FDA in the U.S., MDR in the EU, MHRA in the U.K.).

• Interpret and apply applicable medical device regulations and standards, including ISO 13485, ISO 14971, and IEC 62304, as well as regional requirements.

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Product Registration and Submission:

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• Prepare and manage regulatory submissions, including 510(k), PMA (Premarket Approval), CE marking (EU MDR), and international registrations.

• Work with technical teams to gather necessary documentation, including design dossiers, technical files, and clinical evaluation reports.

• Lead interactions and negotiations with regulatory agencies to gain device approvals, responding to any questions or requests for additional information.

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Labeling and Marketing Compliance:

 

• Review and approve labeling, advertising, and promotional materials to ensure they are compliant with regulatory standards.

• Ensure that all claims made on product packaging, websites, and other media are scientifically substantiated and comply with regulatory requirements.

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Quality and Risk Management Support:

 

• Collaborate with Quality Assurance to implement quality management systems (QMS) in line with ISO 13485.

• Contribute to risk management activities, ensuring the application of ISO 14971 standards for risk assessment and mitigation throughout the product lifecycle.

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Cross-functional Collaboration:

 

• Provide regulatory guidance to R&D, Labeling department, Manufacturing, Quality Assurance, and Marketing teams during product design and development.

• Participate in product design reviews to address regulatory requirements and ensure product designs meet compliance standards.

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Clinical Evaluation and Post-Market Surveillance:

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• Oversee clinical evaluations and post-market surveillance activities, as required by regulatory authorities.

• Support post-market vigilance, adverse event reporting, and field corrective actions, including product recalls, if necessary.

• Manage processes for capturing post-market data, analyzing it, and reporting it in accordance with regulatory guidelines.

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Audits and Inspections:

 

• Prepare the company for audits and inspections by regulatory authorities.

• Conduct internal audits and gap assessments to identify compliance issues and recommend corrective actions.

• Lead responses to regulatory audit findings and work with cross-functional teams to ensure corrective actions are implemented.

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Regulatory Intelligence and Training:

 

• Monitor changes in medical device regulations, standards, and guidance documents.

• Inform and train relevant internal teams on regulatory changes and their potential impact on product development and marketing.

• Serve as a regulatory expert within the company, providing guidance on emerging trends and compliance practices.