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Regulatory Engineer – Level II at Veran Medical
St. Louis, MO, US
  • Coordinate product marketing clearance and certification activities with respect to planning, scheduling and submitting regulatory documents (e.g. – 510(k)s, letters to file, product licenses) based upon a thorough knowledge of FDA regulations, guidance documents and international licensing requirements
  • Represent regulatory affairs and assure proactive relationship in various cross-functional meetings and project teams with engineering, operations, marketing, quality and clinical affairs to ensure that all products are and remain in compliance
  • Review and approve product and process change orders to ensure regulatory and standards compliance
  • Review and approve product labeling to ensure accuracy in supportability of claims and to ensure fulfillment of product labeling requirements
  • Prepare regulatory filings as appropriate
  • Prepare and submit adverse events as appropriate to affected regulatory bodies
  • Perform risk management activities per ISO 14971 and participate in product risk analysis activities
  • Perform internal regulatory audits to verify compliance of products with applicable safety standards and technical construction reports
  • Participate in product design reviews to identify potential design issues and to assist project teams with design solutions
  • Other tasks as assigned

 

Qualifications:

  • Bachelor’s degree preferred OR demonstrated equivalent experience
  • 5 to 8 years of relevant medical device industry experience, preferred in Regulatory Engineering
  • RAPS Regulatory Affairs Certification preferred, but not mandatory
  • Knowledge of ISO 13485:2016, FDA Quality System Regulation, MDR knowledge preferred
  • Good record-keeping and attention to detail
  • Proficient in product & process development concepts, including change control, design verification and validation and risk management
  • Problem solving abilities for medical device and process improvements
  • Excellent written and verbal communication skills, including ability to communicate technical information
  • Good recordkeeping and attention to detail
  • Experience in medical device submissions for 510(k), CE certification, etc. preferred
  • Ability to read, write and speak English
  • Proficient in product & process development concepts, including change control, design verification and validation and risk management
  • Organizational skills, detail oriented, trustworthy