Senior Regulatory Affairs Specialist

Catalyst

Senior Regulatory Affairs Specialist


  Huntsville,
Posted
3 weeks ago
Duration
Permanent/Fixed Term
Salary
$90,000 - $110,000
Sector
Regulatory Affairs

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An opportunity to join an established medical device manufacturer that has been in the industry for 50 years. You’d be joining their Regulatory and Quality team to assist in the creation, preparation, and coordination of regulatory submissions and approvals in the domestic and international market. This is for someone with Regulatory Affairs experience that wants jump into a senior position with more independent responsibilities.

 

Responsibilities

  • Ensure the company’s products and operations are compliant with applicable regulatory requirements for Class II devices including FDA, EU MDR /MDD, ISO 13485:2016, and other international regulations
  • Assist in developing and creating policies and procedures under regulatory compliance
  • Prepare and execute premarket notifications to the FDA
  • Collaboratively work and report directly to the Director of Regulatory and Quality
  • Manage multiple regulatory projects simultaneously

 

Requirements

  • 5+ years of Regulatory Affairs experience in Medical Devices and EU MDR/MDD
  • BA degree or higher in a life sciences related field
  • Strong working knowledge of FDA, CFR’s, ISO 13485 Regulations, EU Medical Device Regulations, CE Marking, and 510(k)’s
  • Ability to work independently and collaboratively with a team

 

 

 

For more information, please contact me at:

Madison.lai@catalystcareers.com or 929-626-8424

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Apply Now

Contact

Email
+44 (0) 20 3589 9300
 

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