Regulatory Open Forum

Job Title:  Regulatory Affairs Specialist

 InBios specializes in the design, development, and manufacture of immunodiagnostic devices. Since its inception, the company's mission has been to focus on emerging infectious diseases and the underserved healthcare community. As such, InBios has specifically targeted those diseases that afflict tens of millions of people worldwide. InBios is committed to serving the global marketplace by providing superior quality products that are accurate, easy to use and cost effective. The company is FDA registered, USDA licensed, and ISO 13485:2003 Certified.

 Located in the dynamic South Lake Union area of Seattle, Washington the company is seeking to add an experienced regulatory affairs specialist to the InBios team. This individual will work with senior management to implement the company's regulatory strategy in support of product clearances and approvals with FDA and international regulatory bodies.

 Specific job duties include:
• Assist in the preparation and submission of pre-submissions, 510(k)s, and PMAs to the FDA as well as the preparation of technical files in support of CE marking

• Prepare, review, and approve labeling and SOPs
  • Maintain regulatory files in a format consistent with requirements
  • Support regulatory activities relating to specific portfolio of products/projects (product owner)
  • Maintain and update existing regulatory authorizations
• Represent or lead Regulatory Affairs in project teams throughout product life cycle
• Stay current with regulatory requirements and trends and knowledge of regulatory regulations as it pertains to clinical field studies preferred.

Qualifications
• BS in life sciences, and at least 2 years of experience in an FDA-regulated medical device manufacturing company
• Advanced degree or certification in regulatory affairs or equivalent experience in the medical device industry

• Knowledge of US and international IVD regulations
  • Strong written and verbal communication skills
  • High attention to detail
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Ability to manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary

 Along with competitive base salary, insurance benefits, and 401(k), there is potential for performance-based rewards. Committed to work/life balance, InBios also provides paid time off including a weeklong shutdown during December.

Job Title:  Regulatory Affairs Specialist

 InBios specializes in the design, development, and manufacture of immunodiagnostic devices. Since its inception, the company's mission has been to focus on emerging infectious diseases and the underserved healthcare community. As such, InBios has specifically targeted those diseases that afflict tens of millions of people worldwide. InBios is committed to serving the global marketplace by providing superior quality products that are accurate, easy to use and cost effective. The company is FDA registered, USDA licensed, and ISO 13485:2003 Certified.

 Located in the dynamic South Lake Union area of Seattle, Washington the company is seeking to add an experienced regulatory affairs specialist to the InBios team. This individual will work with senior management to implement the company's regulatory strategy in support of product clearances and approvals with FDA and international regulatory bodies.

 Specific job duties include:
• Assist in the preparation and submission of pre-submissions, 510(k)s, and PMAs to the FDA as well as the preparation of technical files in support of CE marking

• Prepare, review, and approve labeling and SOPs
  • Maintain regulatory files in a format consistent with requirements
  • Support regulatory activities relating to specific portfolio of products/projects (product owner)
  • Maintain and update existing regulatory authorizations
• Represent or lead Regulatory Affairs in project teams throughout product life cycle
• Stay current with regulatory requirements and trends and knowledge of regulatory regulations as it pertains to clinical field studies preferred.

Qualifications
• BS in life sciences, and at least 2 years of experience in an FDA-regulated medical device manufacturing company
• Advanced degree or certification in regulatory affairs or equivalent experience in the medical device industry

• Knowledge of US and international IVD regulations
  • Strong written and verbal communication skills
  • High attention to detail
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Ability to manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary

 Along with competitive base salary, insurance benefits, and 401(k), there is potential for performance-based rewards. Committed to work/life balance, InBios also provides paid time off including a weeklong shutdown during December.