US
0 suggestions are available, use up and down arrow to navigate them
What job do you want?

Regulatory Affairs Associate/Manager/Director (Hiring all Levels) job in Atlanta at

Create Job Alert.

Get similar jobs sent to your email

List of Jobs and Events

Apply to this job.
Think you're the perfect candidate?
Apply Now
Regulatory Affairs Associate/Manager/Director (Hiring all Levels) at

Regulatory Affairs Associate/Manager/Director (Hiring all Levels)

Work From Home, GA Contractor
Apply Now
  • Looking for Regulatory Affairs Professional with all amounts of experience. Manager is looking for entry and sr level people with experience in the medical device industry.
  • Should be able to write submission, review changes, the device we’re bringing to market is a Class III (Transcatheter, mitral valve replacement – really early in the process) so great opportunity to get in, huge room for growth etc.
  • Representing Regulatory Affairs with Cross functional team – should have experience having gone through submission process, will review docs going to FDA, notified bodies… and responsible for submitting, reviewing design & regulatory changes, and impact assessment.
  • Preferred experience in CE MDD Technical File experience or submission experience, US submission experience, and International submission experience.
  • Prior experience authoring MDD Technical Files, US/CE submissions, and/or addressing regulatory agency questions is a plus.
  • Prefer (not required) experience in EU MDR submission activities, including representing RA in project meetings, STED compilation, publishing/submission to regulatory body, corresponding with regulatory agency to address questions.

  • Ensure global regulatory compliance (FDA, MDD, CMDR)
  • Address regulatory compliance and other regulatory policy issues
  • Lead worldwide regulatory affairs and develop regulatory strategy, implement strategy and manage efforts of regulatory staff
  • Ensure a global regulatory strategy
  • Identify and implement process improvements for regulatory affairs
  • Build a regulatory affairs department to support current and future clients in regulatory oversight and support regulatory filings
  • Manage timelines for regulatory submissions
  • Assist Denmark, German regulatory affairs
  • Develop and oversee the strategic plan for regulatory affairs
  • Establish national regulatory affairs and market development strategy and plan
  • Develop global regulatory strategies and update based upon regulatory changes
  • Provide strategic state government affairs guidance
  • Direct and prepare regulatory submissions
  • Facilitate meetings with regulatory agencies
  • Support regulatory product submissions or registrations
  • Provide support for international registrations and support to global regulatory affairs teams
  • Facilitating compliance with all regulatory requirements, including interface with regulatory agencies
  • Manage all regulatory projects, developing and executing regulatory plans
  • Direct the reimbursement and regulatory affairs of client facilities
  • Manage the regulatory group that perform regulatory and quality compliance functions

Recommended Skills

  • Impact Assessment
  • Regulatory Filings
  • Regulatory Requirements
  • Market Development
  • Strategic Thinking
  • Regulatory Compliance
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job:

CareerBuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.