Regulatory Affairs Specialist

Exciting 2 year development contract onsite opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses in Surgical and Vision Care.Regulatory Affairs Specialist I2 year contract$40.00-$45.52 per hourCoordinate, prepare, or review regulatory submissions for domestic or international projects.Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Compile and maintain regulatory documentation databases or systems.Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions).Communicate with internal stakeholders regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentationReview product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.Review clinical protocols to ensure collection of data needed for regulatory submissions.Write or update standard operating procedures, work instructions, or policies.Education:Bachelor's Degree - no specific Field of study.Experience with Regulatory Affairs U.S., EU and Canada SubmissionThis job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Created: 2025-01-15