Regulatory Affairs Associate II (Hybrid)

This position is hybrid in Salt Lake City, Utah as it will require a few days onsite per month. If the individual hired meets the qualifications for the Regulatory Affairs Associate III then they will be hired at a level III.

The Regulatory Affairs Associate II will assist the Regulatory Affairs Director with the development, implementation, and ongoing management of the organization’s regulatory affairs compliance programs, to ensure compliance with applicable regulating agencies and align with industry standards. The Regulatory Affairs Associate II will have interactions with individuals at most position levels within the organization and contact with representatives from external regulating agencies. The Regulatory Affairs Associate II will operate as an integral member of the Regulatory Affairs team by leading certain regulatory affairs projects and furthering collaboration of the regulatory affairs programs, with emphasis in assigned areas of focus.

The Regulatory Affairs Associate II provides support and leads activities related to regulatory affairs both domestically and internationally, including coordination, development and maintenance of all regulatory submissions. The submissions will include but are not limited to Investigational Device Exceptions, Pre-Market Approvals, Supplements, Changes, six-month interval reports, annual reports, IVDR, UKCA and regulatory submissions for other countries. This role works closely with the Quality and Compliance teams and various departments in coordinating document/records management along with completing some administrative tasks. The role also includes scheduling required submissions and providing assistance so that the submissions are prepared timely and accurately.

Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:

Responsibilities

• Receives general instruction on routine work and detailed instructions on new projects or assignments. May provide guidance to lower level employees.
• Assists in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior.
• Gathers regulatory information and provide suggestions for improvement to departmental management, if applicable
• Addresses common and easy problems with well understood solutions. Occasionally seeks guidance from others to find solutions and/or overcome obstacles
• Continually improves knowledge of current and pending revisions to regulatory compliance guidelines and safety requirements.
• Establishes and maintains a calendar for 6-month and annual reports to the domestic regulatory agencies and other global regulatory bodies. Schedules other required submissions such as 30-day pre-approvals for changes and helps to facilitate submissions.
• Tracks all pending submissions and provides assistance so that all submissions are executed in a timely fashion. Work with Document Control to load all submissions into Master Control for electronic approvals and long-term storage.
• Helps to design and manage templates for cover letters, IDE, PMA, Application Forms, Summary of Technical Documentation (STED), Facility Registrations, Changes, and Supplements etc. so that the submissions will be standardized and have the appropriate language and content.
• Helps to write and organize submissions with the appropriate templates to include table of contents, legal required language, appendixes, etc.
• Additional duties as assigned by supervisor.

Qualifications

• Bachelor's degree in Engineering, Life Science, or other technical discipline (or equivalent experience)
• 2-8 years related professional experience, including direct experience in regulatory affairs (preferably medical device).
• Regulatory Affairs certification is preferred.
• Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations.
• Strong research, analytical, and problem-solving skills.
• Ability to set priorities and adapt to changing business needs and manage multiple assignments within established time frames.
• Ability to work independently and on projects with a team and filling various roles such as team member, facilitator, etc.
• Ability to efficiently use computer programs necessary to complete work requirements (MS Word, Excel, PowerPoint, etc.).
• Additional Qualifications for Regulatory Affairs Associate III:
  • 6-10 years related professional experience, including a minimum of 3 years direct experience in regulatory affairs (preferably medical device). Advance degree could account for additional experience.
  • Regulatory Affairs certification is highly preferred
    

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