Position Summary:
- The Regulatory Affairs Specialist’s primary responsibilities are to support a broad range of regulatory functions at BioFire Defense, particularly those relevant to development of new in vitro Diagnostics (IVDs) as well as maintenance of existing IVDs and regulated industry products. The Regulatory Affairs Specialist will assist in coordination and preparation of regulatory submissions, ensuring compliance with FDA and Health Canada, as well as other applicable requirements. The Regulatory Affairs Specialist will participate in labeling review and recommend changes for labeling for regulatory compliance; familiarity with MDSAP, FDA, OSHA, RoHS, REACH, UL, GMP, and ISO13485/9001 requirements is preferred. The Regulatory Affairs Specialist will ensure quality system compliance for the Regulatory Affairs group, including writing and revising relevant SOPs/WIDs, and constructively implementing compliance mechanisms for new regulations and regulatory guidance. The Regulatory Affairs Specialist will also assist with post-market activities including post-market surveillance, adverse event reporting, and field actions. This position also supports external party audits (Auditing Organization, Regulatory Body, Notified Body, Supplier, Customer, and Contractor audits) to represent regulatory responsibilities. The Regulatory Affairs Specialist will contribute to planning, oversight, and management of projects and duties for the Regulatory Affairs group. Collaboration with personnel in multiple company departments is required to understand the products and maintain/implement new policies/procedures.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality Management System
- Supports the development and validation of in vitro diagnostic (IVD) reagent test kits and their associated systems primarily through quality system documentation.
- Watch for new US and applicable international regulations and FDA and Health Canada guidelines; provide periodic updates to select groups.
- Participate in labeling review and recommend changes for labeling for regulatory compliance; familiarity with MDSAP, FDA, OSHA, RoHS, REACH, UL, GMP, and ISO13485/9001 requirements preferred.
- Review and approve product labeling, advertising promotional materials related to BioFire’s regulated products to ensure compliance with regulatory requirements.
- Help prepare and submit documents to the FDA, Health Canada, and other regulatory bodies as needed.
- Support communications with regulatory bodies and maintain contact logs.
- Assist with regulatory strategy development and transition planning for new IVD products.
- Support GUDID project and UDI compliance for all IVDs.
- Establish and conduct post-market surveillance for IVD and combined use products.
- Support post-market activities including adverse event reporting and field actions.
- Review and assess product change impacts (device/labeling) for US, Health Canada, and international markets and craft regulatory notification plans.
- Work with Quality Assurance Team on audits, complaint investigations, NCRs, CAPAs, medical device reporting, and recalls.
- May be asked to contribute to grant/proposal/SOW writing with reference to regulatory capabilities at BioFire Defense.
- Use professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
- Maintain and write SOPs and WIDs relevant to the Regulated Affairs Group.
- Oversee creation of annual Quality Plans that include quality objectives and performance KPIs for the Regulatory Affairs group. Facilitate and report on progress in periodic Quality Reports and Management Review.
- Maintain and provide regulatory input to design history documents.
- Assist with various administrative and oversight tasks for the Regulatory Affairs group.
- Occasional supervision and support of Research Associates for Regulatory tasks and projects.
- Support hiring, training, mentoring, and professional development for the Regulatory Affairs group.
- Must be available to support Audits.
Training and Education:
- BA/BS, preferably in a scientific field or equivalent years of regulatory technical experience; M.S. in a biomedical discipline and Molecular Biology experience preferred.
- Certification of ISO13485 Lead Auditor Training with 21 CFR 820 (preferred, may be acquired post-hire).
Experience/Skills:
- 2-5 years of experience in regulatory or related technical field.
- Excellent written and verbal communication skills.
- Solid organization skills including attention to detail and multitasking skills.
- Understand and apply applicable regulations within the QMS, including explaining regulations to other team members and communicating regulatory requirements to superiors to ensure compliance.
- Strong working knowledge of Microsoft Office and project management skills.
- Ability to work independently and proceed with priority objectives with minimal supervision.
Benefits and Compensation:
- We offer competitive salaries
- 401k
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment
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