Device Regulatory CMC - Manager (Contract) 793

Vertex Pharmaceuticals LLC; United States; Remote; USD 103,000 - 110,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Chemistry Manufacturing Controls Manager – Device to support global regulatory CMC strategies for drug-device combination products. You will help prepare submissions and provide regulatory support across cross-functional teams to ensure compliance with global requirements.

The role involves reviewing CMC sections for submissions, developing global strategies, and serving as the primary regulatory contact for assigned products, including device development

Qualifications

• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs).
• Proficiency in regulatory guidelines (FDA, Notified Bodies, MDCG, EMA, ISO).
• Experience reviewing regulatory submissions/filings for drug-device combinations.

Responsibilities

• Reviews CMC sections of regulatory submissions for development and commercial device programs.
• Develops global regulatory CMC strategies for commercial drug-device products.
• Collaborates with cross-functional teams and serves as regulatory CMC contact for projects.
• Reviews device development documentation to support design controls of drug-device products.
• Supports regulatory assessment and guidance on product compliance topics such as change controls.

Skills

Regulatory knowledge

Cross-functional collaboration

Regulatory guidelines

Problem solving

Communication

Planning & prioritization

Design Controls & Standards

Education

Bachelor's degree in Biomedical/Mechanical/Related Life Science

Job description

Job Description

The Chemistry Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Key Duties and Responsibilities

• Reviews CMC sections of regulatory submissions in support of development and commercial device programs

• Contributes to the development of global regulatory CMC strategies for commercial drug-device combination products
• Participates effectively on cross-functional teams (including device product development, quality, clinical development, human factors, analytical development, marketing) and may serve as the primary regulatory CMC contact for assigned products and projects
• Reviews device development documentation as needed to support design controls of drug-device combination products
• Supports regulatory assessment and guidance on product compliance topics including change controls and process improvement

Required Education Level & Experience

• Bachelor's degree, with a preference in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science field

• Typically requires 4 years of experience in the medical device, pharmaceutical industry or related field, or the equivalent combination of education and experience

• Experience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringes
• Experience supporting Human Factors studies for devices and combination products
• Preferred experience with infusion systems/devices for drugs/cell therapies

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)

• Proficiency in regulatory (FDA, Notified Body, MDCG, EMA, ISO, etc.) guidelines

• Strong problem-solving skills

• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner

• Strong sense of planning and prioritization, and the ability to work with all levels of management

• Sound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)

Pay Range

$75-$80/hr

No C2C or Third-Party Vendors