Parsippany Troy Hill,
Job Number: 9298
The Market Access Specialist is responsible for regulatory submission activities as well as maintaining regulatory support for existing in vitro diagnostic products. The Specialist leads or assists in the preparation, review, filing and control of regulatory documents.
Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities, including the collection and organization of information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
Create and maintain an electronic or hard copy filing system for organizational records, regulatory submission documents, etc.
Ensure archived material is properly categorized and accessible.
Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications. Procure and organize reference materials from various sources including peer-reviewed scientific journals, government publications, and reputable websites.
Evaluate research data, put together presentations for management with recommendations, and maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
Identifies the need for new regulatory procedures and SOPs and leads development and implementation of such.
Continually improves the quality of policies, programs and services provided.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Evaluates the regulatory environment and provides internal advice throughout the product lifecycle (e.G., concept, development, manufacturing, marketing) to ensure product compliance.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Provides, as required, regulatory input and approval for changes and classification of changes to DHF, DMR and QS records/documentation.
Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Evaluates proposed products for regulatory classification and jurisdiction.
Maintains information systems (electronic and paper) for regulatory information and reports and ensures compliance with Quality System regulations.
Reviews and edits complex technical documents for clarity, grammar, spelling, punctuation and consistency in English.
Ensures that the clinical and nonclinical data--in conjunction with regulatory strategy--are consistent with the regulatory requirements and support the proposed product claims.
Maintain FURLS listings and support the provision of CFGs.
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Up to 10%, including international, travel.
Bachelor's degree required in Sciences or Engineering. Advanced degree a plus. Focus in Biology, Chemistry, Mechanical Engineering, or Computer Science preferred.
3+ years of applicable work experience related to in vitro diagnostic products.
Ability to operate the Microsoft suite of products (Excel, PowerPoint, Project) and Adobe Acrobat.
RAC certification (U.S. And/or devices) preferred.
Excellent written and verbal communication skills.
Demonstrated ability to provide information used to evaluate proposed products for regulatory classification and jurisdiction.
Understands scientific and health principles related to healthcare product development and regulations.
Proven to anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
An ability to work co-operatively and effectively with others to establish and maintain strong working relationships with team members both locally and internationally.