The Manager of Regulatory Affairs oversees and directs the regulatory group to develop and implement strategies and policies consistent with NuProbe’s company goals in an ever-changing regulatory climate. The manager ensures that regulatory strategies and policies are understood, compliant, successful and align with corporate goals. This position ensures regulatory compliance in both a development, medical device, CLIA and commercial environment. The manager will prepare and assist in defending regulatory filings as needed.
Reporting to the Sr. Vice President, Quality and Regulatory, the successful candidate will manage internal Regulatory Affairs professional staff and/or consultants and direct and implement advancement of the Regulatory Affairs function at NuProbe.
PURPOSE OF THE JOB
Integrate traditional Regulatory Affairs responsibilities with an emphasis toward regulatory compliance, surveillance and continuous refinement.
Assist in annual corporate execution planning for RA/Quality leadership team.
Sit on Medical device/ISO 9001 concurrent projects and provide RA advice in a changing global regulated environment; manage scope, schedule, issues/risks, trade-offs, communications and expectations.
Deliver execution excellence in Regulatory Affairs:
Ensure customer-centric, best-in-class thinking into the product design process while considering a diverse product line and regulatory classification.
Drive collaborative discussions and decisions with all key stakeholders with the goal of achieving alignment and pathway forward.
MAJOR DUTIES AND RESPONSIBILITIES
Direct and assemble the preparation and submission of regulatory agency applications, reports, or correspondence.
Provide initial correspondence and responses to regulatory agencies regarding product information or other issues.
Develop and maintain RA standard operating procedures or local working practices.
Assist in establishing regulatory priorities or budgets and assist in overseeing resources and workloads.
Maintain current knowledge of relevant regulations, including proposed and final rules. Disseminate findings to the Senior VP RA/QA.
Participate in the development or implementation of clinical trial protocols.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Monitor emerging global regulatory changes and determine and initiate changes to organizational processes, products in the field and promotional material to ensure compliance.
Assist with domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Review materials such as marketing literature or user manuals, social media, and website to ensure compliance.
Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
Train staff in regulatory policies or procedures.
Other duties as assigned.
Education and/or Job Experience:
Bachelor’s degree (B.S./B.A.) minimum, preferably in a scientific/technical discipline (e.g., biology, chemistry, engineering).
Minimum of 3-5 years of industrial experience in Regulatory Affairs preferred.
Previous experience in research, medical device and consumer products preferred.
Stage-gate product development process experience with global companies preferred.
Strong cross-group skills and ability to communicate effectively, including the ability to get what you need from others while working around their own legitimate priorities.
Ability to work in a complex, rapidly changing environment.
Strong prioritization and organizational skills.
Demonstrated strong problem-solving skills.
Travel up to 25%.
Special Skills, Abilities, and Requirements:
Adaptability, flexibility and the ability to do the right thing under pressure and tight deadlines in a complex, matrixed environment.
Demonstrated ability in developing a program management function within a multi-disciplinary technical environment.
Operational leadership and an understanding of partner and customer requirements.
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Strong leadership skills particularly the ability to influence stakeholders.
Advanced written, oral, and interpersonal communication skills.
Able to work closely with highly technical teams and quickly understand multi-disciplinary concepts.
High attention to detail and accuracy required.
Bachelor’s degree in bioengineering or related field; advanced degree preferred.
Statistical knowledge a plus.
3+ years of experience in a cGMP pharmaceutical or biotech company leading regulatory and/or quality systems.
In-depth knowledge of global regulatory and quality system requirements.
Proven regulatory surveillance capabilities.
Proficient with clinical/commercial programs and global regulatory submissions and product commercialization requirements.
Working knowledge of FDA Quality System Regulations, (21 CFR Part 820), ISO 13485 Quality Management for Medical Devices and Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Strong scientific and analytical skills with an emphasis on critical thinking and problem solving.
Outstanding written and verbal communication skills including presentation effectiveness.
Ability to coordinate and influence across various parts of the company and with multiple external stakeholders.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Can travel domestically and internationally, up to 25%.
Employer will assist with relocation costs.
Internal Number: 05302021
About NuProbe USA, Inc.
NuProbe USA is the US-based R&D subsidiary of NuProbe Global, a company that recently raised $62M YTD to develop novel non-invasive DNA. Its technology enables precise and comprehensive capturing of disease signatures with uniquely high sensitivity and multiplexing capability. NuProbe technologies can reduce the cost of NGS by 50-fold and improve the sensitivity of qPCR, Sanger, and nanopore sequencing by over 100-fold. NuProbe's technologies and products are globally recognized, and NuProbe has multiple partnerships with leading sequencing companies such as Illumina, Oxford Nanopore, and QIAGEN, and hospitals such as MD Anderson, Baylor College of Medicine, and Yale School of Medicine. As a global company, NuProbe also has a China site based in Shanghai and cGMP facility in Suzhou. NuProbe is co-founded by Prof. Peng Yin at Harvard University, Prof. David Zhang at Rice University, and Dr. Victor Shi (former founding president of Qiagen Asia).