- Join our dynamic team at BioFire Defense as we develop and support medical devices with high public health impact, including COVID-19 diagnostics. Entry-level position or internship that gives the opportunity to gain hands-on learning experience about regulations within the medical device industry, assist members of the Regulatory Affairs team by providing organizational and informational support for global regulatory activities, and gain exposure to the development process associated with bringing a new product to market.
The Regulatory Affairs Assistant’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), formatting, assembling, and timely preparation of regulatory submission documents, reviewing labeling and marketing materials for regulatory compliance, and assisting with post-market surveillance of IVD and other regulated products. The RA Assistant 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.
Familiarity with FDA, Health Canada, MDSAP, IVDD, IVDR, ISO, OSHA, RoHS, REACH, UL, GMP, UDI, and ISO13485/9001 requirements is desired, but may be learned on the job.
Collaboration with personnel in multiple company departments is required to understand the products and implement new policies/procedures. Excellent writing skills and attention to detail are essential.
Note: This is an on-site (non-remote) position. Part time options available to accommodate ongoing degree enrollment.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System.
- Organize, update, and maintain regulatory documentation in accordance with department and company procedures.
- Support the Regulatory Affairs team with the following tasks:
- Coordinate and collect information from various departments (e.g., R&D, Clinical, QA, Operations, etc.) to support regulatory projects, as needed
- Organization, formatting, and preparation of documents for international regulatory submissions
- Assist with regulatory assessments and strategies for developing or changing regulated products.
- Review and provide input to design history documentation and labeling for compliance
- Assist with follow-up and data management for post market surveillance activities
- Assessment of product change impacts (device/labeling) for US and international markets.
- Assist with adverse event reporting and field actions.
- Participate in the review of new regulations and development of internal procedures for compliance.
- Conduct research about new regulations and guidance documents and provide periodic updates to varied audiences
- Support QA team with audits, complaint investigations, quality system monitoring, and CAPAs.
- Use professional concepts to achieve objectives in creative and effective ways
- Maintain and organize regulatory data in controlled department spreadsheets
- Organize and maintain records of communications with regulatory bodies or internal meetings
- May be asked to assist with clinical investigations, such as coordinating logistical support to clinical study sites and supporting IRB approvals.
Training and Education:
- No previous experience required. Previous writing or science background preferred.
- Ability to work effectively with multiple disciplines and personalities.
- Self-starter, with the ability to work and learn independently.
- Demonstrate initiative and can work both independently and collaboratively in a team structure.
- Strong attention to quality/detail.
- Strong interpersonal and communication skills (written and verbal).
- Ability to handle multiple tasks and priorities.
- Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
- Excellent organizational, time management, and administrative skills.
Benefits and Compensation:
- We offer competitive salaries
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment