Senior Director - Regulatory Affairs
Full-Time
Aspira Women's Health is a technology-based health care company dedicated to the discovery, development and utilization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. With over 10 years of experience in ovarian cancer risk assessment, Aspira Women's Health has expertise in cutting edge research to develop the next generation of products. We are dedicated to improving the lives of women through innovative health solutions.
About the Job
The Senior Director – Regulatory Affairs has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities. The position provides guidance and oversight relative to local, regional, national and international regulatory laws, standards and regulations.
Essential Job Functions and Duties
Regulatory Submissions
- set strategy for product regulatory submissions to health authorities worldwide, including 510(k), de novo, PMA, and CE Mark MDD Technical File
- oversee organization and compilation of product regulator submissions and other correspondence to U.S. and international regulatory agencies;
- maintain up-to-date knowledge of the data, information and formats required for inclusion in these applications;
- utilize regulatory expertise and knowledge of regulatory requirements to strategically interpret, plan and communicate requirements to ensure governmental approvals are obtained.
Health Authority Interaction
- interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues and the approval of applications;
- effectively plan, organize and conduct formal meetings/teleconferences with regulatory agencies.
Regulatory Compliance
- conduct internal compliance audits in accordance with applicable regulatory standards;
- review, analyze and approve technical data generated by Research and Development, IT, Marketing, Clinical Research, Quality Assurance or other related departments for labeling and filing requirements;
- lead participation in external audits;
- review and provide interpretative analyses of regulatory guidance documents, regulations, proceedings or directives that impact Aspira's products and operations.
Internal Advisor Activities
- provide input and recommendations for device design and process verification and validation in conjunction with other internal groups;
- develop regulatory strategic plan;
- participate on project teams and promote device regulatory updates and summaries to senior management.
Other
- support patent portfolio strategy and applications;
- maintain, in collaboration with Legal and Technology functions, HIPAA tracker and Incident Report;
- partner cross-functionally for training on health care regulatory framework;
- recruit, manage and develop regulatory staff;
- maintain corporate confidentiality at all times.
Minimum Requirements
- Bachelor/Master's degree in engineering or a related life sciences area;
- A minimum of 10 years experience implementing, maintaining or supporting 21 CFR 820, GMP, GCP, ISO 13485:2016, MDD (93/42/EEC), MDD (98/79/EC).
- Required experience with CLIA/NYSDOH/CAP labs;
- Experience and knowledge of U.S. and European current regulatory processes and prior interaction with key regulatory authorities;
- Excellent oral and written communication, interpersonal and organizational skills and attention to detail;
- Ability to consistently meet tight timelines and deadlines;
- Ability to interact effectively with management and prioritize multiple projects;
- Ability to work in a team environment and willingness to work a flexible schedule;
- Technical proficiency, effective problem solving and critical thinking skills;
- Excellent presentation skills.
How to Apply for This Position
Aspira Women's Health is committed to a policy of equal employment opportunity. In keeping with our policy, Aspira Women's Health will recruit, hire, train and promote the most qualified individuals without regard to race, color, creed, gender, gender identity and expression, religion, marital status, domestic partner status, age, national origin, military or veteran status, physical or mental disability, sexual orientation or any other considerations made unlawful by federal, state or local laws. https://aspirawh.com/
The above job description is intended to describe the general nature and level of work. It is not to be construed as an exhaustive list of responsibilities, duties or required skills.
Please email resume to resumes@aspirawh.com
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Tatiana Black, RPh. PharmD
Lakeway TX
United States
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