This client develops, manufactures, and markets a broad range of innovative diagnostic products. They are seeking a Regulatory Affairs Manager who can manage a small team of Regulatory professionals and oversee regulatory submissions for pre-market IVD products. You will work closely with cross-functional teams and provide regulatory guidance to support new product development. This company offers a competitive salary, comprehensive employee benefits, and a collaborative environment. Now is an exciting time to join this dynamic and growing organization!
- Ensure that new products and documentation related to new product design, development, transfer, validation/verification, labeling, and regulatory submissions are compliant with applicable quality and regulatory requirements.
- Manage and lead a small team of technical regulatory affairs professionals, including hiring, performance evaluations and coaching.
- Oversee and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives.
- Author and review technical protocols and data in support of clinical trials, validation, verification and product manufacturing.
- Provide direction and oversight of evaluation of the regulatory impact of changes associated with product design change and routine change control.
- Review and provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
- Participate in and/or oversees department projects.
- Conduct training of new employees and review training documentation for co-workers to ensure compliance to regulations.
- Initiate, review, approve and/or facilitate approval of Quality System Records.
Knowledge and Skills:
- BS degree in a scientific field.
- At least five years of experience in regulatory affairs for diagnostics and/or medical devices.
- Must have some regulatory experience with In Vitro Diagnostics.
- Experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs)
- Demonstrated knowledge of FDA regulations, In Vitro Device Directive and other national and international regulations and standards.
- Prior experience with medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
- Experience applying ISO 14971 principles to medical devices throughout all stages of the product’s lifecycle.
- Previous experience supervising or managing direct reports.
- Demonstrated strong leadership, project management, organization and oral and written communication skills.
- Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Computer proficiency required, including Word, Excel and database management.
- Professional certification (RAC/ASQ) is preferred.
NOTE: All applicants must be authorized to work in the United States. Our client cannot support visa sponsorship or an H1B transfer.