Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare.
Our Regulatory Affairs Manager is responsible to manage, evaluate, and complete regulatory projects and maintain compliance to regulatory requirements consistent with organization goals. This individual must be a leader who can work with significant autonomy and independent judgement to achieve and lead regulatory projects with cross-functional teams. This individual must possess interpersonal skills to develop strong working relationships with both internal and external customers to influence and enable success of the regulatory function and the organization.
We are building a fully integrated Operations team to work closely with our technology and product development teams to empower the scientific community and accelerate our collective impact on humanity. We are looking for self-motivated candidates that are excited by a startup environment where opportunity to rise to frequent and diverse challenges is commonly encountered.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
- Interface with consultants, notified bodies, or health authorities to understand regulatory requirements.
- Lead regulatory and compliance activities and prepare the organization for regulatory responses or submissions.
- Compile and maintain regulatory documentation and database.
- Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
- Review Engineering Change Order (ECO) and assures Design Changes are within compliance requirements.
- Review CAPAs, Nonconformance Report, and Complaints and assure quality events are assessed for compliance impact.
- As a Core Team member, coordinate regulatory project activities with cross-functional teams to manage deliverables, timelines, and resources.
- Train cross-functional teams on the regulatory environment and compliance deliverables.
- Knowledge and experienced in US, EU, or other international medical device submission requirements.
- Proficient knowledge of medical device regulations (21CFR), MDD, regulations and standards including ISO 13485 and 14971, IEC 60601-1 and other related standards.
- Strong interpersonal skills with the ability to collaborate closely cross-functional teams.
- Must be detail-oriented and able to multi-task and manage multiple projects.
- Working Experience with a commercial Quality Management System strongly preferred.
- Strong analytical skills, reporting, and data analysis are strong preferred.
- Ability to work in a fast-paced and technically challenging environment where drive is critical to success.
EDUCATION AND EXPERIENCE:
- S./B.A. degree in Engineering, Biology, Molecular Biology, Microbiology, or related science field (an equivalent combination of experience and education may be considered).
- A minimum of 5 years of experience, preferably in medical device or life sciences industry.
- Must be able to lift 15 pounds.
- Domestic and international travel up to 15%
We are passionate about our mission to develop high performing products to study genomics in unprecedented flexibility and to understand biology for the improvement of healthcare. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness. We offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives.
We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status, or any other characteristics protected by law.