We are looking for Regulatory Specialist for our client in Mansfield, MA
Job Title: Regulatory Specialist
Job Location: Mansfield, MA
Job Type: Contract - 12 Months / Contract to Hire / Direct Hire
- Min 5 year of exp
- Regulatory Specialist with exeperince in Medical device regulatory filings of
- Change notification for EU
- Technical File
- 3-5 years of exepereince in Medical Regulatory
- Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements
- Expereince in Labelling & Packaging related compliances
- Prepare 510(k), Technical File, CE Mark, and other related regulatory filings.
- Support IDE and PMA submission preparation as requested
- Provide regulatory affairssupport to design teams and the document control/change request system.
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
- Organize regulatory information resources and track and control submissions.
- Provide status information to regulatory management as required
- Ensure the timely and accurate filing of regulatory documentation.
- Develop and maintain product technical files.
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
- Participate in compliance activities that relate to the department and the company as a whole.
- Perform other regulatory affairs duties when requested.
- Technical writing skills.
- Experience with data analysis/statistical such as MiniTab or equivalent
- Ability to perform all assigned tasks, work independently, and complete work on schedule
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
- Strong problem solving skills and efficient management of time and resources