Logo for CooperSurgical Fertility Solutions

Regulatory Affairs Specialist

Role overview

Summary

This role supports global regulatory activities for medical devices and life science products at the company. You will develop regulatory strategies and manage submissions while collaborating with cross-functional teams to ensure compliance throughout the product lifecycle.

Qualifications

  • Experience in regulatory affairs for medical devices or life science products.
  • Knowledge of regulatory requirements and compliance processes.
  • Ability to prepare and maintain regulatory submissions.
  • Preferred: Experience interacting with regulatory authorities and external partners.
  • Preferred: Strong communication skills for cross-functional collaboration.

Responsibilities

  • Support global regulatory activities throughout the product lifecycle for medical devices and IVDs.
  • Develop and execute regulatory strategies and prepare regulatory submissions.
  • Manage global product registrations and maintain technical documentation.
  • Provide guidance to cross-functional teams on product development and compliance initiatives.

Key facts

Hard skills

Other skills

  • Packaging And Labeling
  • Communication
  • Problem Solving

About the company

CooperSurgical Fertility Solutions logo

CooperSurgical Fertility Solutions

  • Medical Devices
  • Large
  • 1,001–5,000
CooperSurgical Fertility is the global leader in IVF and reproductive genetics, providing innovative products and services for every step in the ART journey. Alongside CooperSurgical Medical Devices, a leader in manufacturing trusted and innovative brands to help improve the health of women, babies and families worldwide, we are owned by The Cooper Companies. Building on the high-quality reputation of our legacy companies ORIGIO, SAGE, Humagen, The Pipette Company (TPC), K-Systems, Research Instruments (RI), Wallace®, LifeGlobal® and CooperGenomics, we provide a trusted system of consumables, equipment, technologies and genetic testing for the complete ART process. Operating as a seamless organization, with unmatched product breadth, scientific knowledge and geographical reach, our unified approach opens the door to extensive possibilities for the future. We can help drive and evolve innovation in line with customer needs; offering tailored product solutions, delivering world-class evidence-based training, and organizing expert-led workshops. As trusted brands, our products and services continue to meet stringent standards, and our high-quality manufacturing facilities and genetic testing laboratories have been specifically designed for the development of ART products and services. Working with experts and key opinion leaders in the field, we have dedicated research and development teams. They are continually developing innovative products, revolutionary technology and services using the latest clinical research, to help improve clinical workflows, processes, productivity and outcomes. In doing this, we aim to increase the quality of our partnerships with clinics across the globe and the quality of treatments for women and families.

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

The Regulatory Affairs Specialist II supports global regulatory activities throughout the product lifecycle for medical devices, in vitro diagnostics (IVDs), and life science products. The role develops and executes regulatory strategies, prepares and maintains regulatory submissions and technical documentation, manages global product registrations, and supports ongoing compliance with applicable requirements.

The Specialist II serves as a regulatory partner to cross-functional teams by providing guidance for product development, design and manufacturing changes, labeling, market expansion, and compliance initiatives. The role also supports interactions with regulatory authorities, notified bodies, international representatives, and external partners.  

Related jobs

See all Regulatory Affairs Specialist jobs

Other jobs at CooperSurgical Fertility Solutions