What are the responsibilities and job description for the Senior Regulatory Specialist (m/f/d) - IVD position at Agilent?
Description
As a member of the Agilent Regulatory Affairs organization and reporting to the Manager of Regulatory Affairs for Biomolecular Analysis, this individual would develop and implement programs and processes to ensure that company products are safe, meet customer needs, and aligned with regional, national, and global regulations.
Preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal, and annual registrations, and maintains updated information about regional, national, and global regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort, and identifies and mitigates areas of risk.
Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to authorities’ requests / inquiries and / or internal partners dealing with regulations and product compliance.
Represents company through exchanges with external bodies dealing with standards and / or product regulations at the national / regional / global level.
May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
Key Role Responsibilities :
- Provide regulatory input and guidance on medical device Hardware and Software to various stakeholders
- Work collaboratively with cross-functional teams across the intersecting business divisions to develop regulatory strategies to bring IVD, and non-IVD product solutions to the global market. Ensure applicable regulatory requirements are incorporated into the product development life cycle
- Serve as the primary regulatory representative on new product introduction and new product or process improvement projects for instruments (including embedded software and firmware) and associated reagents / consumables used in NGS, microarray, qPCR, and other bioanalysis applications, providing regulatory guidance to cross-functional teams and documenting regulatory strategy in accordance with applicable local and national regulatory requirements
- Responsible for creation and maintenance of Declaration of Conformity, STED / technical file / design dossier, GSPR checklist and other regulatory conformity assessment documents and records in accordance with applicable local and national regulatory requirements
- Provide regulatory review, guidance, input and approval on IFUs, Safety User Manuals, Labels, CAPAs, NCMRs, Deviations, Marketing and Promotional Content Materials and product changes
- Maintain UDI device registration information in applicable regulatory databases, such as GUDID, EUDMAED, etc.
- Ensure compliance with applicable regulations and international standards for products throughout product life cycle
This position is preferably based in our Waldbronn office in Germany (hybrid model) but can also be based remotely in Germany or in our offices in Little Falls (Delaware) or Santa Clara (California) in the USA.
Qualifications
We offer :
Additional Details
This job has a full time weekly schedule. It includes the option to work remotely.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at : Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.
Travel Required : Occasional
Shift : Duration :
No End Date
Job Function : Quality / Regulatory
