Device Regulatory CMC - Manager

Jobgether SRL; United States; Remote; USD 103,000 - 110,000; Full time

Benefits offered by this job

Remote work within the United States

Competitive hourly rate $75-$80

Job summary

Jobgether SRL is seeking a Regulatory CMC Specialist to support global regulatory activities for marketed and development-stage drug-device combination products. You will shape regulatory strategies and help create high-quality submissions across global markets, collaborating with device development, quality, clinical, human factors, analytical development, and commercial teams.

The role focuses on autoinjectors and pre-filled devices, keeping up to date with FDA, EU MDR, and other standards.

Qualifications

• Bachelor's degree in life sciences or engineering.
• 4 years in medical device/pharma regulatory.
• Experience with regulatory submissions for drug-device combinations.
• Knowledge of Human Factors studies for medical devices.
• Familiarity with FDA, EU MDR, and GSPRs.

Responsibilities

• Review CMC regulatory submissions for development and commercial device programs.
• Contribute to global regulatory CMC strategies for drug-device combinations.
• Serve as regulatory CMC contact for assigned products and provide guidance to cross-functional stakeholders.
• Collaborate with device product development, quality, clinical development, human factors, analytical development, and marketing teams.
• Review device development documentation supporting design controls for drug-device combinations.
• Provide regulatory assessments and recommendations related to product compliance, change controls, and process improvements.
• Help ensure global regulatory requirements are incorporated into development and commercial programs.
• Communicate complex regulatory information clearly to stakeholders and management.

Skills

Regulatory affairs

Design Controls

cGMP

FDA/EU MDR knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

Biomedical Engineering

Regulatory Affairs

Job description

This role supports global regulatory CMC activities for marketed and development-stage drug-device combination products.

You will help shape regulatory strategies and contribute to high-quality submissions across global markets.

The position works closely with multidisciplinary teams spanning device development, quality, clinical, human factors, analytical development, and commercial functions.

You will provide regulatory guidance throughout product development and commercialization, helping teams address compliance requirements effectively.

The role offers the opportunity to work on combination products such as autoinjectors, pre-filled pens, and pre-filled syringes.

You will also contribute to device documentation, design controls, change assessments, and process improvements.

Success in this position requires strong regulatory judgment, collaboration, organization, and the ability to translate complex requirements into practical guidance.

Accountabilities

• Review CMC sections of regulatory submissions supporting development and commercial device programs, ensuring content is accurate, complete, and aligned with applicable requirements.
• Contribute to global regulatory CMC strategies for commercial drug-device combination products.
• Serve as a regulatory CMC contact for assigned products and projects and provide guidance to cross-functional stakeholders.
• Collaborate with device product development, quality, clinical development, human factors, analytical development, and marketing teams.
• Review device development documentation supporting design controls for drug-device combination products.
• Provide regulatory assessments and recommendations related to product compliance, change controls, and process improvements.
• Help ensure global regulatory requirements are appropriately incorporated into development and commercial programs.
• Communicate complex regulatory information clearly and provide practical guidance to stakeholders and management.

Requirements

• Bachelor's degree required; preferred fields include Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another relevant life-science discipline.
• Approximately 4 years of experience in the medical device, pharmaceutical, or related industry, or an equivalent combination of education and experience.
• Experience supporting regulatory submissions or filings for drug-device combination products, particularly autoinjectors, pre-filled pens, and/or pre-filled syringes.
• Experience supporting Human Factors studies involving medical devices or combination products.
• Knowledge of combination-product and device regulatory requirements, including FDA requirements, EU MDR, and applicable GSPRs.
• Familiarity with regulatory guidance and standards from organizations such as FDA, Notified Bodies, MDCG, EMA, and ISO.
• Strong knowledge of Design Controls, cGMP, and relevant standards including ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, and ISO 11040.
• Preferred experience with infusion systems or devices used with drugs or cell therapies.
• Strong interpersonal and communication skills, with the ability to exchange complex information and guide cross-functional teams.
• Strong problem-solving, planning, prioritization, and organizational skills, with the ability to work effectively across different levels of management.
• Ability to collaborate openly and communicate in a clear, complete, timely, and consistent manner.

Benefits

• Contract opportunity with an estimated compensation range of $75--$80 per hour.
• Remote work opportunity within the United States.
• Opportunity to support global regulatory strategies for innovative drug-device combination products.
• Exposure to multidisciplinary teams across regulatory, engineering, quality, clinical, human factors, analytical, and commercial functions.
• Opportunity to contribute to both development and commercial-stage programs.
• Potential eligibility for overtime pay in accordance with applicable federal and state requirements.
• Compensation and any applicable benefits are provided according to the terms of the third-party employment arrangement.

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