Regulatory Affairs Specialist

3 weeks ago


Scottsdale, Arizona, United States Innovative Health LLC Full time
Job Description

Innovative Health LLC is seeking a highly skilled Regulatory Affairs Engineer to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with FDA regulations and international standards for medical devices.

Key Responsibilities:
  • Prepare and submit 510(k) submissions to obtain FDA clearance for commercial distribution of medical devices;
  • Develop and maintain regulatory documents for international regulatory bodies, including technical files and design dossiers;
  • Review and approve test protocols, reports, and other documentation for regulatory submissions;
  • Participate in project development teams and review plans, reports, and risk assessments associated with product and process projects;
  • Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;
  • Conduct internal and external audits and prepare responses to support audit findings;
  • Review and approve change orders, CAPA, and nonconformance reports;
  • Assist with label and IFU development and review for compliance;
  • Review promotional material to ensure compliance with applicable regulations;
  • Implement and maintain unique identifier (UDI) activities for compliance;
  • Assist with FMEA risk assessments;
  • Maintain and disseminate current knowledge base of existing regulations, standards, and guidance documents;
  • Develop and implement company policies and procedures;
  • Assist in archiving regulatory documentation and maintaining related repository.

Qualifications:

  • Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field);
  • Experience and knowledge of FDA 21 CFR Part 820 and 510K submission requirements;
  • Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP, and ISO standards preferred;
  • Minimum of three years medical device experience;
  • Working knowledge of QMS systems and functionality;
  • Previous 510(k) submissions preferred;
  • Ability to work in a fast-paced, collaborative team environment;
  • Ability to handle multiple projects and coordinate cross-functional teams;
  • Ability to communicate effectively with management, direct reports, and external vendors;
  • Ability to write technical documents (procedures, test methods, protocols, and reports);
  • Ability to recommend technical solutions;
  • Ability to specify regulatory requirements for products;
  • Ability to work with little supervision;
  • Ability to use personal computers, including software such as: Word, PowerPoint, Excel, Project, and Minitab;
  • Self-starter and highly motivated.


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