[Hiring] Device Regulatory CMC Manager @Vertex Pharmaceuticals

Role 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.

• 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

Qualifications

• 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

Requirements

• 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.)

Benefits

• Pay Range: $75-$80/hr
• This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”).
• The individual selected for this role will be offered the role as an employee of a third-party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
• This role will be eligible for overtime pay, in accordance with federal and state requirements.