Senior Regulatory Affairs Specialist - Lifelancer

Employer Industry: Medical Device Manufacturing

Why Consider This Job Opportunity

• Salary up to $125,100
• Potential for annual performance bonus and comprehensive medical/dental/vision benefits
• 401K match and other applicable compensation plans
• Opportunity for career advancement within a leading medical device company
• Supportive and collaborative work environment with cross-functional teams
  
  

What To Expect (Job Responsibilities)

• Independently plan and coordinate medical device regulatory submissions across various international markets
• Provide regulatory strategy and assess the impact of changes on existing products
• Review and approve marketing communication materials while ensuring compliance with regulations
• Support external audits and maintain communication with regulatory authorities regarding submissions
• Create and update departmental standard operating procedures (SOPs)
  
  

What Is Required (Qualifications)

• Bachelor's Degree (BA/BS) in Engineering, Life Sciences, or a healthcare-related discipline
• 3-5 years of experience in medical devices regulatory submissions
• Proven experience with 510(k) submissions and international registration processes
• Strong organizational skills and ability to multi-task effectively
• Proficient in MS-Office Applications and knowledge of quality system requirements
  
  

How To Stand Out (Preferred Qualifications)

• Experience with FDA, Health Canada, and international regulatory agencies
• Advanced degree and/or Regulatory Affairs Certification (RAC)
• Strong communication skills with the ability to present information effectively
• Experience in supporting international registrations and knowledge of medical device regulations
• Ability to negotiate with regulatory agencies and solve regulatory issues
  
  

#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveSalary #HealthcareIndustry

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