Director of Regulatory Affairs
Our team is growing and we currently have an immediate opening for a Director of Regulatory Affairs.
In this position, you will lead and execute the regulatory strategy for novel, blood-based tests for early detection of cancers including the preparation, review, and submission of regulatory packages (510(k), De Novo, PMA, PMA supplements, and IVDR Technical Files) supporting new product development and throughout the product lifecycle. You will be responsible for leading the development and implementation of regulatory initiatives that ensure our organization is compliant with relevant laws and regulations. You’ll collaborate cross-functionally with internal teams, including clinical, R&D, quality assurance, manufacturing and external consultants to help us stay ahead of the curve in an ever-changing regulatory landscape.
Location: Cleveland, OH
Essential Duties and Responsibilities
- Develop and implement regulatory strategies for new and existing products to support approval/clearance of products domestically and licensing and registration internationally throughout the product lifecycle.
- Prepare, review, and submit regulatory packages (510(k), De Novo, PMA, PMA supplements, and IVDR Technical Files) supporting new product development and throughout the product lifecycle.
- Maintain product approvals and complete all necessary notifications, supplements, amendments, listings, and yearly reports for products on a worldwide basis.
- Develop and implement RA strategy for product development and design changes. This may include counselling R&D/Tech Support project team leaders as to product design and required field and in-house studies to support regulatory strategies as well as regulatory requirements for manufacturing process changes.
- Collaborate cross-functionally with internal teams, including clinical, R&D, quality assurance, manufacturing, to prepare, review, and submit high-quality regulatory submissions, including PMA, 510k, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
- Research and analyze information related to regulatory compliance and develop appropriate strategies to ensure compliance.
- Monitor and track changes in the regulatory environment and provide timely updates to key stakeholders.
- Develop and implement policies and procedures for regulatory compliance.
- Develop and maintain relationships with regulatory authorities and other stakeholders.
- Represent the company at meetings and conferences related to regulatory affairs.
- Provide support and guidance to other departments on regulatory affairs matters.
- Perform all other duties as assigned
Education and/or Work Experience Requirements:
- Bachelor’s degree in science or medical related field.
- Certification such as RAC from the Regulatory Affairs Professionals Society preferred.
- 10+ years of regulatory affairs experience in the IVD/Medical Device industry supporting regulatory strategies and preparing FDA or ex-US submissions of in vitro diagnostic (IVD) products, such as 510(k)s, and/or PMAs submissions, and/or technical files Experience with eCTD requirements or electronic submissions.
- Hands-on experience in the preparation of regulatory and technical submissions, reports and documentation or in the implementation of quality management systems (e.g. ISO 13485, ISO 9001, 21 CFR 820, IVDR, MDSAP or equivalent), preferably in the medical device or diagnostics environment.
- Extensive knowledge of US FDA device regulations, including, but not limited to FDA regulations regarding medical devices and labeling, cGMPs, etc.
- Knowledge and ability to develop, review, and approve technical literature and promotional materials to ensure consistency and compliance with domestic promotional regulations.
- Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations.
- Basic COVID-19 vaccination is required