Regulatory Affairs Manager - Biomatrica Inc.

Summary of Major Responsibilities:

The Regulatory Affairs Manager position is responsible for the preparation of regulatory submissions required to market in vitro diagnostic devices in both domestic and international markets. This position requires the development, execution, and management of procedures to ensure that the product development process meets all regulatory requirements.

Essential Duties and Responsibilities:

• Prepare and manage regulatory submissions (e.g., pre-submissions, IDE, PMA, Technical Files, and other regulatory documentation) for product approvals required by the U.S. FDA and ex-U.S. regulatory bodies.
• Assist in the planning and designing of analytical and clinical validation studies, as well as post-market studies, to support U.S. FDA, CLIA, and ex-U.S. regulatory requirements.
• Facilitate cross-functional teams to ensure timely execution of all deliverables for regulatory submissions.
• Remain current on regulatory issues and trends to anticipate regulatory changes that may impact future or current projects and effectively communicate this information to stakeholders.
• Identify and communicate potential risks and mitigations associated with regulatory strategies to key stakeholders.
• Work closely with quality assurance to ensure design controls are implemented properly during the product development process.
• Review and provide regulatory feedback on technical documents.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.

Qualifications:

Minimum Qualifications

• Bachelor's Degree Biology, Chemistry, Physics, or other similar scientific field.
• 2+ years of experience in the medical device and diagnostic industry.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Experience in regulatory IVD areas.
• Experience with clinical laboratory regulations, such as CLIA state licensing, CAP, and ISO13485.
• Direct experience authoring premarket submissions, such as IDE, and PMA.
• Experience participating in audits by regulatory bodies, such as BIMO and notified bodies.
• Expert understanding of regulatory landscape and requirements for IVDs in the U.S.
• Strong technical background in latest genomic technologies.
• Ability to understand and interpret clinical validation and analytical validation data.
• Demonstrated ability to meet project deadlines.
• Excellent interpersonal skills; including strong written and verbal communication, collaboration, and organizational skills and attention to detail.
• Ability to develop and maintain professional relationships with internal and external subject matter experts to obtain necessary support for product documentation or submissions.
• Openness to diverse views, candor in assessing and articulating difficult positions, and willingness to make changes when needed.

EEO Disclosure:

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.