What are the responsibilities and job description for the Regulatory Affairs Expert position at ProKatchers LLC?
Job Title : Senior Regulatory Affairs Specialist/Medical Writer
Duration : 8 Months Contract
Company Overview:
- ProKatchers LLC is a leading company in the medical device/diagnostics industry, providing high-quality solutions to its clients.
Job Description:
- We are seeking an experienced Senior Regulatory Affairs Specialist who will be responsible for coordinating Performance Evaluation documentation updates within a cross-functional team of reviewers.
- The ideal candidate will have experience in Medical Writing, Quality Documentation, or Project Management in the medical device/diagnostics industry.
- The successful candidate will lead discussions to revise and finalize document updates, as well as drive document approvals in the quality system.
- They will ensure that documentation adheres to current quality procedures and templates.
Required Skills and Qualifications:
- Strong understanding of regulatory affairs and quality documentation principles.
- Excellent communication and leadership skills.
- Ability to work in a fast-paced environment and meet deadlines.
- Experience with quality management systems and documentation software.
Benefits:
- A competitive salary package.
- Ongoing training and professional development opportunities.
- A collaborative and dynamic work environment.
