- Title: Regulatory Affairs Associate
- Code: RCI-05656
- Location: Saint Paul Minnesota (MN) 55117
- Posted Date: 10/08/2020
- Duration: 6 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Position will start remote but the candidate would need to go onsite once or twice a week.
MAIN PURPOSE OF ROLE
- This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
- Supports necessary regulatory activities required for product market entry.
- Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational
- Creates, reviews and approves engineering changes.
- Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- May interface directly with FDA and other regulatory agencies if so directed.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management
- Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Bachelors Degree Technical discipline preferred an equivalent combination of education and work experience
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong organizational and follow-up skills, as well as attention to detail.