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Regulatory Affairs (Southern CA)

Confidential, CA · Biotech/Pharmaceutical
Do you have experience with electro-mechanical medical devices?
  • Develop global regulatory strategies for product submissions and regulatory compliance activities.
  • Prepare, submit, and maintain 510(k)s, technical files and international regulatory submissions, including content, format, and regulatory registration impact, etc.
  • Role may manage people and/or projects.
  • Participate as a core team member for development projects.
  • Review product design and change documentation.
  • Review domestic and international labeling for compliance to labeling requirements,
  • Develop and maintains domestic and international submissions.
  • Review international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements.
  • Provide regulatory review and approval for domestic and International product marketing communications.
  • Experience with sterile disposable products.  Familiar with product bio-compatibility, sterilization, and packaging requirements.
  • Provide regulatory guidance as needed.
 
QUALIFICATIONS
  • Bachelor’s degree
  • 5-7 years of professional experience
  • Experience with software and electro-mechanical medical devices.
  • Knowledge of current FDA regulatory requirements and trends for medical device Pre-market Notifications.
  • Experience with sterile disposable products. 
  • Familiar with product bio-compatibility, sterilization and packaging requirements.
  • Ability to influence and work with personnel at all levels and functional boundaries.
  • Ability to represent Regulatory Affairs in multiple environments (Such as Marketing and R&D)
  • Good prioritizing, organization, interpersonal, communication and analytical skills.
  • Knowledge of software, instrument and disposable design practices.
  • Knowledge of ISO, EU, MDD, EU MDR and Canadian regulatory requirements.
 
PREFERRED
  • Ability to read, analyze, and interpret regulatory literature and documents. Ability to format regulatory submissions that conform to prescribed style and format. Ability to effectively communicate information to peers and management. Ability to translate regulations and guidelines into terms that employees can understand.
  • Ability to calculate figures and amount such as proportions, percentages etc.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability present complex regulatory information to cross-functional groups in clear and concise manner.
Broader Intelligence
OFFICE:  262-223-3211
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