Position

Status

Department

Position Summary:

• The Regulatory Affairs Associate will assist the Regulatory Affairs team with formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations. The Regulatory Affairs Associate will support review of labeling and marketing materials for regulatory compliance; familiarity with FDA, Health Canada, IVDD, IVDR, ISO, OSHA, RoHS, REACH, UL, GMP, UDI, and ISO13485/9001 requirements is desired, but may be learned on the job. The Regulatory Affairs Associate will support Quality System compliance for the Regulated Products group, including writing and revising relevant SOPs/WIDs, design document review, and constructively implementing compliance mechanisms for new regulations and regulatory guidance. The Regulatory Affairs Associate 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. Collaboration with personnel in multiple company departments is required to understand the products and maintain/implement new policies/procedures. Must be available for on-site audits, and to perform both on and off-Site audits.

Principal Job Duties and Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality system.
• Support the development and validation of in vitro diagnostic (IVD) and other regulated reagent test kits and their associated accessories and 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.
• Assist with international and domestic regulatory submissions.
• Support communications with regulatory bodies and maintain contact logs.
• Maintain current knowledge of existing and emerging domestic and international regulations, standards, and guidelines.
• Interpret regulatory rules, assess rule changes, and ensure their proper communication through corporate policies and procedures.
• Maintain and write SOPs and WIDS relevant to the Regulated Products group.
• Support labeling and marketing material review for regulatory compliance; familiarity with FDA, Health Canada, IVDD, IVDR, ISO, OSHA, RoHS, REACH, UL, GMP, UDI and ISO13485/9001 Requirements desired (may be learned on the job).
• Support GUDID project and UDI compliance for all IVDs.
• Review and assess product change impacts (device/labeling) for U.S. and international markets.
• Conduct post-market surveillance for IVD and combined use products.
• Support post-market activities including adverse event reporting and field actions.
• Work with Quality Assurance Team on internal and external audits, complaint investigations, NCRs, CAPAs, medical device reporting, and recalls.
• Maintain and provide input to design history documents that are central to Regulated Products work.
• Review and assess product change impacts (device/labeling) for US and international markets and craft regulatory notification plans.
• May be asked to contribute to grant/proposal SOW writing with reference to regulated products capabilities at BioFire Defense.
• Contribute to 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.
• Uses professional concepts to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.
• Assist with various clerical and administrative tasks for the Regulated Products group.

Training and Education:

• BA/BS in Science preferred

 Experience/Skills:

• BA/BS in Science (e.g., molecular biology, microbiology, chemistry, biology) preferred, regulatory experience desired.
• Excellent technical writing and communication skills
• Solid organization skills including attention to detail and multitasking skills
• Strong working knowledge of Microsoft Office
• 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