Regulatory Compliance Manager
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 ComplianceManager 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 on submission requirements, leads or support preparation for regulatory responses.
- Compile and maintain regulatory documentation: support marketing and labeling material, regulatory SOPs development, and author technical files or other submission documentation, as required.
- Ensure submissions are maintained and in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
- Review Engineering Change Order (ECO) and assures Design Changes are made within regulatory requirements.
- Review CAPAs, Nonconformance Report, and Complaints and assure quality events are assessed for regulatory impact.
- Coordinate regulatory project activities with stakeholders and manage timelines and resources.
- Train cross-functional teams on the regulatory environment and compliance deliverables.
- Communicate project milestones to Senior Management.
- Thorough knowledge of FDA and ISO 13485 standards, regulations and requirements and working knowledge of other US, EU, and international regulatory requirements.
- Experience and knowledge in preparation and maintenance of the technical review file.
- Strong interpersonal skills with the ability to collaborate closely with Marketing, R&D and Operations staff of varying levels to regulatory projects and deliverables.
- Strong knowledge working with medical device products.
- 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.
- Course program(s) or advanced training in Regulatory Affairs a plus (RAPS, SOCRA, ASQ, etc.).
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 the 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.