Job Description
GENERAL SUMMARY:
The Regulatory Affairs Expert is responsible for developing and executing strategies to support products registrations, entity set-up and ongoing compliance with country-specific requirements. Acting as the local subject matter expert, the role ensures adherence to applicable regulations, including support to economic operator obligations, and may support both locally marketed products and regulatory activities for global portfolios, through submission , licenses maintenance and regulatory body interactions. The position also drives local regulatory intelligence activities, translates evolving requirements into actionable guidance for the business, and ensures compliance with applicable quality systems and regulations, including 21 CFR Part 820, EU 2017/745 (MDR), UK MDR 2002, ISO 13485, and local frameworks.
PRIMARY DUTIES & RESPONSIBILITIES:
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Defines and implement international regulatory strategies to support product registrations, lifecycle management and expansion in assigned markets
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Execute new products submissions and post-approval change management activities in compliance with applicable regulatory requirements.
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Ensure in country regulatory readiness for product launches in alignment with business timelines
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Lead registration, maintenance and compliance of local legal entities and support economic operators obligations, ensuring alignment with applicable regulations and company strategies.
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Monitor and proactively manages the status of regulatory activities, ensuring timely escalation of risks and alignment with business timelines.
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Acts as the primary RA contact with local Authorities, regulatory partners as applicable.
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Respond to customer queries and support the RA portion of tender applications
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Represents International RA in cross-functional teams, ensuring alignment with quality, commercial, supply chain and any other stakeholder as applicable
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Interprets international regulations and provides clear guidance on their impact on local entities, local practices, commercialization and lifecycle management.
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Conducts Regulatory Intelligence and contributes to regulatory advocacy for the defined markets
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Identifies regulatory risks and gaps in plannings and propose appropriate mitigation and strategic solutions.
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Ensures compliance with quality management system and company policies, including legal and regulatory requirements.
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Acts as Tandem representative in internal and external regulatory audits and inspections as needed.
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Ensures continuous exchanges with Tandem corporate to align on regulatory strategy.
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Reviews and analyzes project and customer requirements and assists project teams in tailoring and using regulatory procedures, methods, templates and tools.
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Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
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Ensures accurate documentation and tracking of regulatory activities, submissions and licenses in internal systems.
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Develops, maintains and continuously improves internal regulatory processes and procedures.
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May contribute to health economic dossier preparation
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Other responsibilities as assigned.
REQUIRED QUALIFICATIONS:
Knowledge, skills & abilities:
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Proficient knowledge of regulatory and quality standards: MDR 2017/745, ISO 13485, MDSAP, ISO 14971and other appropriate laws, guidelines and industry standards.
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Knowledge of 21 CFR Part 820 is a plus
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Demonstrated experience communicating with regulatory bodies such as EU, international regulatory agencies and notified bodies.
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Understanding of strategic and tactical role of Global Regulatory Strategy in the product development and commercialization process.
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Ability to analyze, interpret translate and simplify technical content or regulations and communicate to stakeholders.
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Skilled at creating a cooperative team environment.
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A positive approach to people and problem solutions.
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Fluent in French and English (C1 proficiency minimum).
Minimum certifications/educational level:
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Bachelor's degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or equivalent combination of education and applicable job experience.
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Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
Minimum experience:
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10 plus years of related experience in regulatory function in medical device industry.
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Demonstrated experience in leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals, including experience authoring a range of global regulatory submissions, (e.g., 510(k), De Novo, CE Mark etc.) and preparing regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).
JOB SCOPE
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Having wide-ranging experience and resolves complex issues in creative and effective ways.
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Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
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Determines methods and procedures on new assignments and may coordinate activities of other personnel.
