Senior Regulatory Specialist (Clinical)

Arevna; Chicago (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a dynamic and innovative firm as a Senior Regulatory Specialist in the MedTech sector. This role is pivotal in managing regulatory submissions for Class II-III medical devices across various global markets, including the U.S., EU, and China. You will ensure compliance with essential regulatory frameworks while collaborating with cross-functional teams to support product development and market access strategies. If you are passionate about making a difference in the medical device industry and thrive in a fast-paced environment, this opportunity is perfect for you. Your expertise will help shape the future of healthcare products and ensure they meet the highest standards of safety and efficacy.

Qualifications

• 5+ years of regulatory experience in the medical device industry.
• In-depth knowledge of global regulatory requirements for medical devices.

Responsibilities

• Lead regulatory submissions for Class II-III medical devices across regions.
• Provide strategic regulatory guidance to cross-functional teams.

Skills

Regulatory Compliance

Project Management

Communication Skills

Clinical Documentation

Risk Management

Education

Bachelor’s or Master’s degree in Life Sciences

Regulatory Affairs Certification (RAC)

Tools

ISO 13485

FDA 510(k)

EU MDR

Job description

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Head of Commercial @ Arevna | Delivering high performing teams in MedTech.

About the Role:

We are seeking an experienced Senior Regulatory Specialist (Clinical) to support regulatory submissions and clinical documentation for Class II-III medical devices. The ideal candidate will have extensive experience with global regulatory submissions, including NMPA (China's National Medical Products Administration), FDA (U.S.), MHRA (UK), and EU MDR. This role is critical in ensuring compliance with regulatory requirements while supporting product development and market access strategies.

Key Responsibilities:

• Lead and manage regulatory submissions for Class II-III medical devices across multiple regions, including NMPA, FDA, MHRA, and EU MDR.
• Prepare and compile regulatory dossiers, including clinical evaluation reports (CERs), clinical trial documentation, and risk assessments.
• Ensure compliance with Chinese, U.S., UK, and EU regulations, coordinating with local regulatory authorities, third-party consultants, and internal stakeholders.
• Provide strategic regulatory guidance to cross-functional teams, including R&D, Quality, and Clinical Affairs, to support product development and commercialization.
• Monitor regulatory changes and updates in China, the U.S., UK, EU, and other international markets, ensuring the company’s regulatory strategies remain compliant.
• Support the preparation and review of clinical trial protocols, investigator brochures, and informed consent documents.
• Work closely with clinical and quality teams to ensure alignment between regulatory, clinical, and quality requirements.
• Liaise with regulatory agencies to address inquiries, deficiency letters, and pre-submission meetings.

Qualifications & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field.
• 5+ years of regulatory experience in the medical device industry, specifically for Class II-III devices.
• In-depth knowledge of NMPA, FDA, MHRA, and EU MDR regulatory requirements, including clinical evidence requirements, registration pathways, and post-market surveillance.
• Experience preparing clinical documentation such as CERs, clinical trial applications, and clinical study reports.
• Strong understanding of global regulatory standards such as ISO 13485, MDR (EU), and FDA 510(k)/PMA processes.
• Ability to interpret and apply regulatory guidelines and standards to ensure compliance.
• Excellent communication and project management skills, with experience working in cross-functional teams.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

• Experience interacting with regulatory reviewers and regulatory bodies across multiple countries.
• Knowledge of biocompatibility, risk management, and clinical study design for medical devices.
• Regulatory Affairs Certification (RAC) is a plus.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Administrative, Research, and Legal

Industries

• Medical Equipment Manufacturing