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Senior Regulatory Affairs Specialist, Medical Products

Senior Regulatory Affairs Specialist, Medical Products

Exempt/Non-Exempt: Exempt Employment

Type: Full Time 

Description: Support global regulatory submissions and ongoing regulatory compliance through the product development lifecycle.

Duties:

  • Prepare global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other international markets such as Japan, the Far East, Australia and Latin America;
  • Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes;
  • Participate in Risk Management assessments;
  • Review design and manufacturing changes for compliance with applicable regulations; 
  • Support quality system audits by notified bodies, government agencies and customers;
  • Assist with environmental regulations and standards (e.g. RoHS, REACH, etc.);
  • Maintain regulatory files as required by departmental procedure;
  • Perform all other essential duties as assigned.

Qualifications:

  • 5-10 years of experience with US and EU regulatory preparations and submissions of Class II electro-mechanical medical devices;
  • Hands-on knowledge of all phases of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366;
  • Strong working knowledge of Microsoft Word and Excel. Education Required:
  • Bachelor’s degree, preferably in an engineering or life sciences discipline;
  • Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.

Personal Requirements:

  • Excellent oral, written, and interpersonal skills;
  • Must be able to interact with customers and suppliers;
  • Ability to work in a cross-functional environment with competing priorities;

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