Device Regulatory CMC – Manager

Job not on LinkedIn

🕒 Yesterday

🇺🇸 United States – Remote

💵 $75 - $80 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1989

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

📋 Description

• Review CMC sections of regulatory submissions supporting development and commercial device programs • Contribute to global regulatory CMC strategies for commercial drug-device combination products • Participate on cross-functional teams including device product development, quality, clinical development, human factors, analytical development, and marketing • Serve as the primary regulatory CMC contact for assigned products and projects when applicable • Review device development documentation supporting design controls for drug-device combination products • Support regulatory assessment and guidance on product compliance topics, including change controls and process improvement

🎯 Requirements

• Bachelor's degree, preferably 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 • Knowledge of combination product and device regulatory requirements, including FDA, EU MDR, and GSPRs • Proficiency in regulatory guidelines from FDA, Notified Body, MDCG, EMA, ISO, and others • Knowledge of Design Controls, cGMP, FDA, EMA, and ISO standards, including ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, and ISO 11040 • Strong interpersonal, problem-solving, collaboration, communication, planning, and prioritization skills • Ability to work with all levels of management • No C2C or third-party vendors

🏖️ Benefits

• Eligible for overtime pay in accordance with federal and state requirements • Compensation, medical benefits, fringe benefits and other employment terms will be presented by the third-party agency partner upon offer