Senior Regulatory Affairs Specialist

Role: Senior Regulatory Affairs Specialist

Location: Temecula, CA - 92591

Duration: 08+ Months on W2

Shift Timings: 8 AM to 5 PM

Skills Looking For

• Regulatory Submission Experience: Proficiency in US (FDA) and European (CE) regulatory submissions, particularly with Class 3 devices in the US and Class 2B devices in the EU.
• Reviewing and Assessing Changes; reviewing changes and assessing their regulatory impact, including submitting to international regulatory agencies or updating internal documentation to meet regulatory requirements.
• Day-to-day Responsibilities:
  
  

Responsibilities include attending meetings, reviewing and approving changes, collaborating with international regulatory affiliates, and supporting product release authorization.

• Handle the preparation, review, and submission of regulatory documents for US (FDA) and European (CE) regulatory agencies.
• Review and assess proposed changes to products or processes to determine their regulatory impact; evaluate changes for potential risks and ensure that necessary regulatory requirements are met before implementation.
• Work closely with international regulatory affiliates to provide documentation and support for new product registrations, renewals, or changes; coordinate with regulatory counterparts in other countries to ensure compliance with local regulations.
• Support the product release authorization process by ensuring that all necessary regulatory requirements are met before products can be distributed; verifying labeling compliance and submitting requests for distribution approval.
• Maintain regulatory documentation and records in accordance with regulatory requirements and internal procedures; keeping track of submission timelines, approvals, and other regulatory activities.
• Stay updated on changes to regulatory requirements and standards relevant to the medical device industry. Ensure that regulatory activities and submissions align with current regulations and guidelines.
  
  

Education And Level Of Experience

• Bachelor's degree is required.
• The ideal candidate should have 3 to 5 years of experience in regulatory affairs. May consider candidates with 2 years ' experience if they are very strong.
  
  

Top 3 Skills

• Regulatory Submission Experience: Ability to handle US and EU submissions effectively; particularly with Class 3 devices in the US and Class 2B devices in the EU.
• Analytical Thinking: Capacity to assess changes for regulatory impact.
• Multitasking: Skill in managing multiple projects with tight deadlines.
  
  

Interview Process

• One to Two rounds of phone/video interviews.