The scientist’s primary responsibilities are to support a broad range of regulatory functions at BioFire Defense. These responsibilities may include providing regulatory input on new and existing systems (instrument, firmware, software, reagents), writing/reviewing protocols and reports to support regulatory submissions, preparing submission documents, integrating with the Quality System, reviewing labeling, interfacing with sub-contractors, writing standard operating procedures (SOPs) and work instruction documents (WIDs) relevant to regulatory issues, supporting post-market surveillance of IVD products, implementation of compliance with new regulations and guidance, and grant/proposal writing. Familiarity with FDA, OSHA, RoHS, REACH, UL, GMP, IVDD, and ISO13485/9001 requirements is desired, but may be learned on the job.
Collaboration with other scientists and personnel in multiple company departments is required to understand the products and resolve technical issues. Excellent writing skills are integral. Contributions to literature, conferences, funding proposals, and patent applications are expected.
Management of Research Associates is required. Support in drafting and reviewing statements of work and cost proposals is required.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System.
- Supports the development and validation of in vitro diagnostic (IVD) reagent test kits and their associated systems. This may involve supervision of sub-contractors and drafting of related sub-contracts.
- Support the development of Design Control and Risk Management activities.
- Design, write and review study protocols and study reports that are used to support regulatory submissions.
- Manage Research Associates (may or may not be direct reports) for studies.
- Participate in writing of final regulatory documents (e.g., 510(k)) and regulatory submission interactions.
- Oversee the performance of study protocols and data evaluation to ensure that the study is conducted according to the protocol. Oversee data verification activities. Identification of technical issues, accompanied by the proposal and execution of constructive solutions is required.
- Ensure testing and reports are delivered in a timely manner. Delays must be communicated to managers well in advance of due date.
- Maintain broad knowledge of state-of –the –art principles and theories.
- Make contributions to literature, conferences and grant/proposal/SOW writing and patent applications.
- Advise management about scientific issues and regulatory issues related to research and development projects.
- Collaborates with other scientists and personnel in various company departments to resolve technical issues or develop new products.
- Use professional concepts and company’s policies and procedures to solve moderate range of difficult problems in imaginative and practical ways.
- Watch for new US regulations and FDA guidelines; provide periodic updates to select groups.
- Participate in labeling review and recommend changes for labeling for regulatory compliance; familiarity with FDA, OSHA, RoHS, REACH, UL, GMP, IVDD/IVDR, and ISO13485/9001 requirements expected (may be learned on the job).
- May be asked to support post-market activities including complaint investigations and NCRs with regulatory significance, adverse event reporting and field actions (may be learned on the job).
- Support Department of Defense contracting requests coordinated through the BioFire Defense Program Management Team; attend regular meetings with contractors.
- Support bioMérieux requests coordinated through the BioFire Defense Program Management Team; attend regular meetings as requested.
- Work with Quality Assurance Team on audits, medical device reporting, maintaining the Regulatory-related SOPs and WIDS for the Quality System.
- Travel to sub-contractors inside and outside the state may be required.
- Occasional travel to sub-contractors outside the country may be required.
- Occasional travel to BioFire Diagnostics is required.
- Must be available for on-site audits as needed.
- PhD with at least 2 years of experience in development of scientific experiments (may be satisfied in part with post-doctoral training). Some regulatory experience is preferred.
- Strong written and oral communication skills. Basic statistical techniques and proficiency with Microsoft products.
Benefits and Compensation:
- We offer competitive salaries
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment