Senior Regulatory Specialist (m/f/d) - IVD

Senior Regulatory Specialist (m/f/d) - IVD

Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us.

We are searching for a highly motivated Senior Regulatory Specialist (m/f/d) to be part of our Global Regulatory Affairs team where you will play a key role in supporting new product introduction projects and developing regulatory strategies to help bring products to the global market, coordinating and tracking international submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent’s Biomolecular Analysis Division.

General Job 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:

• Bachelor's or master's Degree in biological science or equivalent
• Proficient years of experience within a Regulatory Affairs function is highly preferred – but we are open for someone with a very solid understanding in medical device hardware and software who wants to transition into regulatory affairs
• Experience with IVD or hardware/software medical device systems
• Experience writing and submitting regulatory submissions is an advantage
• Experience working in ISO 13485, MDSAP, IVDR or GMP environment supporting clinical markets is required
• Experience with RoHS (EU, KSA, UAE), EMC, EU Battery Regulation or EU Machinery Regulation is preferred

We offer:

• Competitive compensation and benefits package (yearly company bonus, private health care, pension scheme, discounted stock purchase plan, medical & life insurance…)
• Exciting projects in a dynamic collaborative team grounded on an agile culture
• Career development opportunities in an international company
• Work-Life-Balance is encouraged
• Permanent contract in a fast-growing global company

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.

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: Day

Duration: No End Date

Job Function: Quality/Regulatory