Job Description

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a medical device and ophthalmic product manufacturer in Fort Worth, TX. This role will require you to be onsite.

Title: Regulatory Affairs Specialist

Location: Fort Worth, TX (onsite)

Duration: 24 months with likely extension

w2 Pay: $45.00 hourly

(Mon - Fri, 40 hours)

Job Description:

• 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.
• 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. 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.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• 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.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Write or update standard operating procedures, work instructions, or policies.

Please Note: This position is W2 hourly. Will not respond to C2C, 3rd party agencies, or candidates not authorized to work in the United States.

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