http://www.biofiredx.com/company/career/?p=job%2Fo7hd5fwqDescription
The Regulatory Affairs Specialist will serve as a member of the Regulatory Affairs team and will be responsible for developing regulatory strategy for new IVD products, steering new IVD products through various government/regulatory approval processes, ensuring compliance with various international regulations and, assessing regulatory risks associated with product changes.
Principal Job Duties and Responsibilities
- Develop global regulatory strategy for new products
- Prepare and submit U.S regulatory submissions [Pre-Submissions, 510(k)s, direct de novo applications, etc.]
- Prepare and maintain product Technical files for CE marking
- Analyze and understand regulatory requirements, and identify solutions; provide directions for proper implementation
- Organize and prepare documents for international submissions. Coordinate with international counterparts to obtain product approvals and renewals
- Conduct research on regulatory changes and developments on application requirements
- Collaborate with and provide regulatory insight to new product development teams. Advise project teams on subjects such as premarket requirements, timelines, compliance issues and export and labeling requirements
- Support review of labeling and marketing materials
- Maintain current knowledge of existing and emerging regulations, standards, and guidelines. Assist in keeping the company informed of these requirements
- Prepare product field action and MDR reports
- Interpret regulatory rules, assess rule changes, and ensure their proper communication through corporate policies and procedures
- Review and assess product change impacts (device/labeling) for US and international markets and craft regulatory notification plans
- Assist in the development and review of corporate and department procedures
- Prepare and direct timely preparation of additional information and responses requested by regulatory agencies
Minimum Qualifications
- Bachelor's Degree in microbiology/molecular biology. M.S/Ph.D. preferred
- 3+ years (for Specialist-II), 4+ years ( for Specialist-III) of practice in the field of IVD/MD in an international environment
- Working knowledge of QMS requirements (QSR and ISO 13485)
- Understand of design and change controls
- Familiarity with regulatory agencies/organizations
- Experience in communicating with regulatory authorities
Preferred Skills and Qualifications
- High energy level
- Strong verbal and written communication skills
- Solid organizational skills
- Hands-on, action-oriented, continuous improvement minded
- Comfortable with change
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal.
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Ajay Bhatia
Salt Lake City UT
United States
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