Regulatory Manager

Location
Bethesda, Maryland
Posted
Sep 28, 2021
Ref
2021-10914
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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.

 

Requirements

 

Required qualifications:

  • 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.

 

Preferred qualifications:

  • Prior experience at FDA Center for Devices and Radiological Health (CDRH) is desirable.

 

#LI-DW1

Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.  

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

 

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth. 

 

What you’ll get…

  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.

 

 

 

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.