Director of Regulatory Affairs
The Director of Regulatory Affairs at Amnio Technology, LLC ("AT") has the responsibility for assuring federal and state regulatory requirements are met or exceeded in all aspects of products requiring registration. He/she advises in the areas of regulatory strategic planning and decision making to support the overall company compliance framework, and serves as project lead for regulatory submissions.
Essential Duties and Responsibilities:
- Actively manage the planning, development, implementation and maintenance of regulatory strategy for Amnio Technology products. Consult with all levels of management, business units, internal account/client managers, and internal/external resources to plan, design and secure support for the complete compliance framework.
- Lead all aspects of regulatory submissions, including review of technical documents (clinical and non-clinical information), development and tracking of submission timelines, and preparation of regulatory content to ensure compliance with guidelines.
- Perform risk assessments, gap analyses and develop and implement internal controls to mitigate compliance risk.
- Assist with adverse event reporting. Evaluate adverse events to determine root causes, identify corrective actions and prevent recurrence.
- Lead development of company response to regulatory comments, balloting, data request responses, and event investigations.
- Represent Amnio Technology's position both internally and through direct testimony with regulators, industry, and trade organizations.
- Interpret regulations and provide regulatory/technical advice to operators and planners to mitigate compliance risk.
- Anticipate changes to the regulatory compliance environment, develop and implement associated regulatory strategy, take actions to ensure proactive compliance with federal regulations, and ensure key initiatives are communicated to Amnio Technology leadership.
- Provide regulatory support for corporate Quality efforts.
- Mentor and coach regulatory staff and other team members.
Physical Environment and Working Conditions:
- Full-time position.
- Duties are such that there should be minimal contact with body fluids which may be considered infectious. Such fluids may be present on records received; however, such records should be placed in a plastic sheet for protection.
- Travel by personal auto, charter or commercial aircraft required with reimbursement for personal auto use provided by the company policy, in accordance with IRS policy.
Education and Work Experience Qualifications:
- Minimum of a Bachelor's degree in a medical or scientific discipline, or equivalent. Post graduate degree highly desirable.
- Minimum of eight (8) years regulatory experience in biologics, medical device, and/or pharmaceuticals, including global regulatory experience and substantive IND, IDE, BLA, NDA, PMA and/or 510(k), etc. submission experience. A combination of education and experience may be considered. Regulatory Affairs Certification (RAC) strongly preferred.
- Broad federal and state regulatory compliance knowledge, including requirements for pharmaceuticals and medical device.
- Direct experience with administration and interpretation of clinical trials, including implementation of standard operating procedures for compliant clinical research.
- Strong critical thinking and creativity skills, along with the ability to exercise sound judgment by making decisions based on accurate and timely analyses on a wide range of intellectual and practical problems.
- Ability to prioritize multiple projects, handle crises, and interface effectively with regulators, customers and other stakeholders in order to meet corporate goals.
- Team player with group collaboration skills; ability to lead teams and promote engagement.
- Ability to read, write, analyze and interpret complex documents.
- Excellent communication skills, both verbal and written.
- Highly motivated, task oriented, with strong attention to detail.
- Excellent organizational skills and ability to multitask.
- Self-starter who takes initiative to solve problems and make informed decisions.
- Strong Microsoft Office skills: Excel, Word, Outlook, PowerPoint and SharePoint.
- High degree of honesty and integrity.
Amnio Technology, LLC is a global leader in the development and use of amnion-derived technologies. Amniotic tissue contain key growth factors, cytokines, amino acids, carbohydrates, hyaluronic acid, extracellular matrix (ECM) proteins, and cellular components recognized as intrinsic to the complex wound healing process. Published studies on the benefits and efficacy of amniotic tissue in wounds date back over 100 years. Amnio Technology is focused on optimizing the regenerative potential and clinical use of these unique tissues.
Wed, 12 Jul 2017 15:38:40 PDT