Position Summary
The Regulatory Affairs Specialist is responsible for identifying and obtaining scientific, engineering, and regulatory information for review, preparation, and maintenance of technical documentation for submission to regulatory authorities in the countries/regions where the company wishes to market medical products. This position works with the regulatory authorities, or with the local subsidiaries or distributors taking action on behalf of the company, to ensure compliant market access. In addition, this person is responsible for review of promotional material and labeling for compliance with regulations, overseeing annual establishment registrations and device listings, and supporting on-going compliance projects. This position reports to the Head of Regulatory Affairs for ClearCorrect Operating, LLC.
Job Responsibilities
This position is responsible for, but not limited to, the following:
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Coordinate acceptance and management of requests for regulatory activities (i.e., Orbit requests).
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Generate and review regulatory submissions to obtain compliant market access for distribution of ClearCorrect brand medical products in target markets/regions.
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Produce subsequent regulatory submissions (renewals, annual reports, change notifications, memos to file, etc.) to maintain market access in the target markets/regions (e.g., maintains Technical Files and associated documentation for European Union).
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Work with the regulatory authorities (or the local subsidiary or distributor acting on behalf of the company) to achieve market access.
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Provide input to Product Design teams to assure that regulatory requirements, guidance, and standards are incorporated in the development process; this may include the preparation and maintenance of the associated Regulatory Assessment and Regulatory Strategy documents.
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Author, review, and/or approve certain Product Design documentation, complying with design control requirements to facilitate their use in achieving and maintaining access to the markets in which the company participates.
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Assess product and manufacturing process changes to determine if regulatory action is required.
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Support Unique Device Identifier (UDI) requirements in the target markets/regions.
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Review promotional material and labeling to ensure applicable regulatory and company requirements are met.
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Keep abreast of new or changed regulations, guidance documents, and consensus standards in the target markets/regions and communicate relevant changes to the appropriate company stakeholders.
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Obtain and maintain establishment registrations and device listings in the target markets/regions.
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Release of products in distribution control system upon receipt of market access and support product launch activities.
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Support Freedom of Information Act requests to the FDA as assigned.
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Support logistics/supply chain in providing regulatory information for incoming product shipments.
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Support worldwide registration, including overseeing notarization and legalization of documents and overseeing the request for FDA Certificates to Foreign Government, etc.
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Support specific compliance projects for target markets/regions.
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Other duties where Regulatory Affairs is a stakeholder as assigned.
Minimum Qualifications
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Technical or scientific degree or equivalent related work experience.
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Minimum 2 years of experience in Regulatory Affairs, other work within the medical device industry, or other work in another regulated industry.
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Fluent written and spoken English.
Please note when you apply upload your English version CV
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: Spain : Madrid
Travel Percentage: 0 - 10%
Requisition ID: 19851
