Product Manager(R&D and Regulatory) bei Pluslife

Description

About Us
Pluslife is an innovative biotechnology company specializing in advanced diagnostic solutions for both human and veterinary healthcare. As a fast-growing pioneer in molecular and rapid diagnostic technologies, we are committed to delivering accurate, accessible, and reliable testing products that empower healthcare professionals, laboratories, and consumers worldwide. Our mission is to advance global health through scientific excellence, technological innovation, and high-quality diagnostic solutions.

The company has received multiple honors, including Leading Entrepreneurial Talent and Team, Specialized and Innovative SME, High-Tech Enterprise, and the 2024 Healthcare CSR Model Enterprise.

Powered by proprietary RHAM technology, Pluslife has developed molecular POCT devices and test cards for major infectious diseases, respiratory and reproductive tract infections, and pathogens in companion animals. We have filed over 170 patent and certification applications, with more than 50 granted and 120 approved internationally. Our products are used across countries and regions worldwide.

Responsibilities

1. Own the end-to-end product lifecycle—from concept definition through regulatory submission, launch, and post-launch release management.

2. Partner with R&D, Quality/Regulatory (QA/RA), and Manufacturing to define product requirements, design transfer deliverables, and risk management documentation.

3. Work closely with clinicians, veterinarians, and laboratory stakeholders to identify workflow pain points and translate them into clear user needs and product requirements.

4. Conduct structured market and competitive analysis for diagnostic reagents and POCT systems.

5. Support regulatory strategy and clinical study planning, including pathways such as FDA 510(k), CLIA Waiver, EUA, and (for veterinary diagnostics) USDA-CVB-related requirements.

6. Drive commercialization readiness, including labeling, Instructions for Use (IFU), training programs, and a closed-loop process for post-market feedback.

7. Build and continuously improve internal documentation and processes to strengthen Pluslife’s U.S. product development system and compliance practices.

Requirements

1. 3–7 years of product management experience in IVD, medical devices, or life sciences.

2. Working knowledge of FDA/IVD regulatory frameworks; experience in ISO 13485 and/or CLIA-regulated environments.

3. Ability to bridge scientific details, clinical workflows, and business decision-making effectively.

4. Proven cross-functional collaboration experience (R&D, Regulatory/Quality, Clinical Affairs, Manufacturing, Sales).

5. Excellent written and verbal communication skills, with the ability to align clinical experts, engineering teams, and leadership.

6. Highly structured, analytical, and execution-focused; prioritizes measurable outcomes over theory.

7. Experience in veterinary diagnostics, public health, or POCT diagnostic programs is a plus.