Senior Regulatory Affairs Specialist Hybrid
Senior Regulatory Affairs Specialist Hybrid
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Job Description
As the Senior Regulatory Affairs Specialist you will support new product development and sustaining activities for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will support the product lifecycle by assessing changes made to the device post launch to determine potential regulatory impact the current clearance.
What you will do
Assess regulatory landscape to create the development of global regulatory strategies
Identify requirements and anticipate regulatory obstacles for market access distribution and update regulatory strategy based on changes.
Determine requirements and options for regulatory submission approval pathways and compliance activities.
Provide regulatory information and guidance during product development planning and review proposed product claims/labeling throughout the product lifecycle.
Work with regulatory authorities and tracks review progress through clear communication.
Identify the need for new regulatory procedures SOPs and helps train stakeholders to ensure organizationwide compliance.
Prepare and submit electronic submissions ensuring consistency with regulatory requirements.
What you need
Bachelors in Engineering Scienceor related
3 years of experience in medical device regulatory affairs and/or quality assurance
Preferred
Masters in Regulatory Affairs or Regulatory Science
RAC(s)
Required Experience:
Senior IC
Employment Type
Full-Time
