What are the responsibilities and job description for the Regulatory Affairs Specialist position at Aequor?
- Local (Texas) W2 candidates only. C2C and relocation candidates are not eligible. No H1B /STEM OPT candidates.
- Candidate must be in USA at present and authorized to work in USA.
Job Title: Regulatory Affairs Specialist I
Location: Fort Worth, TX 76134
Duration: 24 months contract - onsite role
Interviews: 1 or 2 (Max would be 2)
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.
Salary : $40 - $44
