The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
The Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR). As a regulatory process expert supporting the IVDR teams, implementing regulatory strategies for IVDR activities; providing regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborating with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
This role will work with Program Managers and technical staff to determine action items and deliverables to address gaps in Quality Systems and product documentation. Assisting in the creation and revision of procedures, forms, and templates to ensure compliance with the IVDR. Writing technical files as per IVDR requirements and managing the review and approval of such documents. Tracking and reporting status of regulatory deliverables to Program Managers and leadership.
Responsibilities will also include securing necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market company’s products in that geography. Ensuring that they sponsor complies with the local regulatory requirements of the country in which the product is marketed. Preparing the necessary documentation, and securing necessary approvals. Responding to regulatory agency inquiries. Applying and/or writing the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity. Managing legalization, Apostilling, and notarizing process.
SPECIAL SKILLS REQUIREMENTS:
Experience preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments
Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 2-4 years of experience in the offered position or related.
Excellent organizational skills and attention to detail
Ability to read, understand, and summarize technical and scientific information
Ability to interpret and apply regulations to company policies and procedures
Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling
Experience working with cross-functional product development teams to ensure regulatory compliance
Implementing global regulatory compliance programs for product corrective actions
Excellent computer based skills, including Microsoft Office (Excel, Word, Powerpoint) and Sharepoint.
Telecommuting is allowed.
Internal Number: 3274398
About Kelly Science and Clinical
At Kelly Science and Clinical, we over achieve, so you can, too.
Getting access to highly skilled, niche talent to power essential functions throughout the developmental lifecycle of a drug or device is no small task. It’s also not enough when it comes to your operational success.
Our Functional Service Provider (FSP) insourced workforce solution goes beyond providing the talent you need to help you achieve more. We’re skilled at creating FSP solutions to fit your unique needs and help you scale up or down effortlessly—whether you’re looking for an end-to-end service, support for a single function, or anything in between.
We cover clinical trials from preclinical studies and phases I-IV, up to real-world evidence and market access.
Our expertise spans functional areas that include:
Clinical operations, drug safety and pharmacovigilance, and regulatory affairs
Biostatistics and statistical programming
Medical or technical writing, medical affairs, quality assurance, lab support, and engineering
Our therapeutic experience includes:
Infectious disease, immunology, and vaccines
CNS, musculoskeletal, and women’s health
Oncology, endocrinology, cardiology, dermatology, and ophthalmology
Medical device and in vitro diagnostic device