Regulatory Affairs Associate II
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Job Description
Regulatory Affairs Associate II at Myriad Genetics ensuring compliance with regulatory standards. Collaborating on regulatory affairs and maintaining documentation for submissions to agencies.
Responsibilities:
- Assist in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior.
- Gather regulatory information and provide suggestions for improvement to department management as needed.
- Address common and easy problems with well understood solutions and seeking guidance from others as needed to overcome obstacles.
- Continually improve knowledge of current and pending revisions to regulatory guidelines and safety requirements.
- Establish and maintain the reports calendar for the domestic and global regulatory agencies, scheduling other required submissions as needed.
- Track all pending submissions, loading into the internal database system for electronic approvals, and long-term storage.
- Help design and manage templates to support standardization of submissions, reviewing submissions to ensure they follow the appropriate template and rewriting as needed.
Requirements:
- High school diploma or GED equivalent required, bachelor’s degree in engineering, life science, or other technical discipline preferred.
- 2+ years of related professional experience and including direct experience in regulatory affairs (preferably medical device).
- 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, adapt to changing business needs, and manage multiple assignments within established time frames.
- Ability to work independently and on a team while filling various roles such as team member, etc.
- Ability to efficiently use computer programs necessary to complete work requirements (MS Word, Excel, PowerPoint, etc.)
Benefits:
- EEO
- Health insurance
- Flexible work arrangements
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