Position Summary:
- The qualified individual will be responsible for coordinating efforts related to the planning, oversight and management of projects, and other assisted duties on behalf of the Quality Assurance (QA) and Regulatory Affairs groups. Proficiency in technical writing is required. The Regulatory Affairs Project Manager will work closely with the QA and Regulatory teams and representatives from other functional groups (R&D, Software, Manufacturing, Finance, Sales and Marketing) to manage development and implementation of new processes, procedures, and work flows, as well as ongoing review and oversight processes to support compliance. Candidates will possess independent work habits, strong organizational skills, enhanced attention to detail, diplomacy, and extensive written and verbal communications skills. The Regulatory Affairs Project Manager will coordinate labeling committee agendas/meetings, and recommend changes for labeling for regulatory compliance; familiarity with FDA, OSHA, RoHS, REACH, UL, GMP, IVDD, and ISO13485-9001 requirements is desired, but may be learned on the job. The Regulatory Affairs Project Manager will assist with ensuring quality system compliance for the company, including writing and revising relevant SOPs/WIDs, assisting with post-market surveillance and field actions, and constructively implementing compliance mechanisms for new regulations, standards, and/or regulatory guidance.
Training and Education:
- Bachelor’s Degree required.
- Master’s Degree in a related field preferred.
- Proficiency with Microsoft Office including Excel, Word, and OneNote required.
- Extensive technical writing experience, organizational skills, and communication proficiency required.
Experience/Skills:
- 3+ years of experience in technical writing, quality assurance, or regulatory setting preferred.
- Experience working in highly regulated environments (FDA, ISO) is a plus.
- Technical Writing
- Adept with Microsoft Office Products
- Project Management
- Organizational Skills, Analysis, and Reporting
Benefits and Compensation:
- We offer competitive salaries
- 401k
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment
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