We are currently searching for a Regulatory Manager to support Structural Heart and Valve Disease Clinical Trials. This opportunity is full-time, and it is on site in Bethesda, MD and/or remote work.
Duties & Responsibilities
- Work in close collaboration with the Principal Investigator, Physicians, and Engineers.
- Compile data related to investigational device and drug safety and compliance in order to prepare and manage regulatory reports, submissions, and queries to the FDA, Institutional Review Boards (IRB, both internal and external), Data and Safety Monitoring Board (DSMB), Clinical Events Adjudication Committee (CEAC), and Institute leadership.
- Assist with the preparation and completion of FDA Investigational Device Exemption (IDE) applications for novel treatments.
- Assist with the preparation and completion of FDA Investigational New Drug (IND) applications for novel medications.
- Provide regulatory expertise and guidance on ethics of clinical research and of privacy, including special considerations for federal and HIPAA-covered agencies.
- Bachelor’s in Biology, Biomedical Engineering, Bioengineering, Nursing or health-related field.
- Experience in FDA regulatory submissions, experience with pediatric cardiovascular disease especially in interventional cardiovascular catheterization labs for structural heart disease is a plus.
- Experience in clinical research data management including analysis, data query management, and audits for cardiovascular device studies
- Expertise with Good Clinical Practice (GCP) regulations and procedures, with proven ability to implement in the design or management of device clinical research.
- Experience interacting with regulatory bodies relevant to the leadership/sponsorship of novel clinical device studies including FDA, IRBs, DSMBs, CEACs, radiation safety boards, etc.
- Prior experience at FDA Center for Devices and Radiological Health (CDRH) is desirable.
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.Company Description
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.
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