DGM - Regulatory Expert Medical Device

Job Description:

Responsibilities

• Develop, document, and maintain end?to?end regulatory strategies for medical devices across the key markets, ensuring alignment with product technology, intended use, risk classification, and business objectives.
• Manage preparation, review, and submission of regulatory dossiers, including: 510(k), PMA, Medical Device License applications, CE marking submissions, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE) submissions ensuring accuracy, consistency, and regulatory compliance of all submissions.
• Maintain the dossiers by filing annual reports and manage post?approval submissions and Lead change impact assessments for Design modifications, Manufacturing and process changes, Supplier and raw material changes, labeling changes by accurately assessing and classifying the changes and prepare and manage change submissions and notifications to agencies.
• Provide regulatory input on Human factors and usability engineering and assess regulatory adequacy of design and development documentation, Device verification and validation etc.
• Review and assess preclinical testing data (bench, biocompatibility, electrical safety, EMC, etc.), Clinical investigation data and performance evidence and ensure clinical and preclinical data meet regional regulatory expectations and are appropriately aligned with device claims and intended use.
• Manage activities related to supplier qualification, CAPAs, complaint handling, product performance and audits
• Act as a regulatory point of contact and prepare and coordinate responses to regulatory authority questions, deficiencies, and follow?ups, with agencies
• Develop and execute engagement strategies with agencies, including Pre?Submission meetings, key regulatory questions, and incorporation of agency feedback into development and submission plans.
• Act as the regulatory strategy lead on cross?functional project teams, translating complex regulatory requirements into actionable development and execution plans.
• Communicate clearly (written and oral) internally (e.g., company personnel) and externally (e.g., regulatory agencies, auditors, vendors)

Qualification & Experience

• Bachelor’s degree in Life Sciences, Engineering, Biomedical Sciences, or related field
• Advanced technical degree (PhD, MBA) preferred
• Experience
• More than 15 years of progressive medical device regulatory experience
• Hands?on experience with: FDA submissions (510(k), PMA, IDE)
• EU MDR and CE marking
• Health Canada device licensing
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