Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Cambridge, MA 02114
About the Job
Responsibilities:
- Your main tasks will be related to the regulatory aspects of the development or improvement of products, including the management and application of Design Controls and the preparation of regulatory submissions and pre-submissions.
- You will also be expected to be a direct contributor to the creation, maintenance, and improvement of the company's regulatory processes.
- As such, you will be interacting not only with your Regulatory Affairs team colleagues but also with members of the R&D, Marketing, and Quality teams.
- Draft / review 510(k) and PMA pre-submissions and submissions.
- Develop / draft internal regulatory processes (e.g., to maintain compliance or improve process efficiency)
- Execute the regulatory aspects of analytical and clinical validation studies for IVD / RUO products (GxP)
- Draft / review Study Plans, Reports, Product Requirements, Risk Management, and other study documentation
- Analyze / review raw and/or processed study data, using appropriate statistical approaches and tools.
- Support management and logistics tasks for clinical trials and/or device development
- Design Requisition Forms, CRF, ICF, etc.
- Draft Lab Manuals for clinical trials; support site training, management, and monitoring
- Actively involved in the reporting and processing of controlled changes, nonconformances, CAPA, etc.
- Lead team response to internal and external audits
- Interact with sponsors, prepare electronic data transfers, etc.
- Perform other duties as assigned.
- Master's degree in Regulatory Science / Regulatory Affairs with 5+ years of experience in a Regulatory role
- Bachelor's degree in a scientific field relevant to IVD development (molecular biology, biochemistry, etc.) with 8+ years of experience in a Regulatory role
- History of 510(k) / PMA (and/or international) submissions for IVD products
- Hands-on pre-sub and submission package preparation for IVD products
- Expertise in relevant regulations and standards, including 21 CFR 820, 21 CFR 58, ISO 14971, etc.
- Experience with / solid understanding of Design Controls and their application in IVD development
- Experience operating under (and contributing to) a Quality Management System
- Experience with Quality processes such as Change Control, Client, CAPA
- Experience working with the Product Development (R&D) team to create controlled products.
- Experience with regulatory / quality inspections and audits
- Outstanding verbal and written communication skills, including English spelling, syntax, and grammar.
- Strong independent thinking, strong organizational and planning abilities, and excellent analytical and problem-solving skills
- Capable of great attention to details
- Ability to exert influence without formal power.
- Ability to work closely with all business processes and functions.
Source : Katalyst Healthcares & Life Sciences