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 I

2 year contract

$40.00-$45.52 per hour

• Coordinate, 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 documentation
• Review 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 Submission

This 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!