Medical Device Consultant

We are seeking an experienced and independent Regulatory Expert / Independent Medical Device Consultant to join our team on a consultancy basis. In this role, you will leverage your regulatory expertise to identify and advise potential clients, guiding them through the complex landscape of global regulatory requirements. As an ambassador of NABI’s services, you will help clients navigate FDA and MDR regulations and recommend tailored solutions to ensure successful market entry.

Responsibilities:

• Act as a regulatory advisor to prospective clients, analyzing their needs and recommending NABI’s regulatory and compliance services.
• Stay updated on the latest FDA and MDR (Medical Device Regulation) requirements and advise clients on the best pathways for US and European market access.
• Identify new opportunities for NABI by researching potential clients and establishing connections in the medical device industry.
• Collaborate with clients to develop tailored regulatory strategies for medical device submissions, including FDA, EU MDR and other international markets.
• Provide continuous updates and expert insights on regulatory changes that may impact the client’s projects.
• Work closely with NABI’s internal team to coordinate client services and ensure smooth project delivery.

Requirements:

• Bachelor’s degree in a Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field.
• Proven experience in the medical device industry, with a focus on regulatory compliance and quality assurance processes.
• Proven ability to advise clients on regulatory strategies, submission processes, and compliance for medical devices.
• Understanding of international medical device regulations, including MDR, FDA QSR, ISO 13485, ISO 14971, and other global standards.
• Excellent communication skills, with the ability to build relationships and trust with clients.
• Ability to work independently and remotely, managing your own schedule and client interactions.
• Familiarity with biocompatibility testing and post-market surveillance is an advantage.

Why Join NABI?

This is a flexible, independent role that allows you to work remotely while collaborating with a highly experienced team. You’ll play a key role in helping clients successfully navigate the regulatory process, ensuring they can bring innovative medical devices to market. This is an exciting opportunity to grow your expertise and make a tangible impact in the medical device industry.

Compensation:

This position will be hired on a B2B basis, with compensation structured around commission.

How to Apply:

Interested candidates should submit their resume, cover letter, and examples of previous work to hr@nabi.bio or use the form below.