Job Summary
This position is responsible to ensure pre-market and/or post-market regulatory activities are in compliance with domestic and international regulations. Working independently, with guidance from manager or more senior staff, the position will participate in team meetings, prepare submission and registration documentation, assess and document device changes, prepare field notifications and vigilance reports, and prepare post-market documentation. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and reports, preparing regulatory documentation, and promoting regulatory compliance.
Key Accountabilities
Post-Market:
Advise and direct teams on regulatory requirements for on-market product changesAuthor regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirementsEnsure company site and device registrations are compliant with applicable domestic and international regulationsEnsure global compliance of post-market surveillance program Author documentation and regulatory strategy in support of global field corrective actions/ recalls and vigilance reportsReview and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as requiredGeneral:Increase working knowledge of regulations, standards, company SOPs and toolsAssist in interactions regarding regulatory affairs with all functional areas of the company as required including senior managementAssist in tracking standards, regulations and all applicable requirementsOther duties as assignedAssesses regulatory gaps and take the appropriate corrective actions, as neededSupports internal and external audit as requiredParticipates in regulatory improvement projects as required
Networking/Key relationships
To be determined based on department needs, to include interactions such as:
Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirementsAbility to negotiate and influence others in establishing direction toward improved regulatory and enhanced complianceAbility to effectively communicate regulatory requirements to a broad population of constituents QualificationsMinimum Knowledge & Experience required for the position:
Education: Bachelor’s degree or higher, preferably in science and/or regulatoryExperience: Minimum of 5-years’ experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years’ experience with an advanced degree
Skills & Capabilities:
Ability to read and interpret domestic and international regulatory/quality standards related to our productsWorking knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirementsDemonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectivesRecognition of when to escalate issues to management or consult with more senior staff members.Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulationsUnderstanding of the application of regulatory principles in the areas of pre-market or post-market complianceKnowledge of FDA, ISO, MDSAP, IVDR, MDR and international country regulationsKnowledge of design control requirements and understanding of GMPLanguage: English
Travel requirements:
< 10% of time
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