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
Requisition Disclaimer
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 pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. 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. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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