Regulatory Affairs Associate

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Regulatory Affairs (ONSITE) on a permanent basis at Cincinnati, OH.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

J****ob Title: Senior Associate, Regulatory Affairs

Employment Type: Full Time

Location: Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek Rd Blue Ash, OH 45242

• Responsible for managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc.
• Coordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval.
• Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions.
• Submit and manage applications for the US FDA Certificates to Foreign Government (CFGs).
• Maintain various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation.
• Perform and/or coordinate legalization, notarization, and apostille of regulatory documents
• Ensure compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping.
• Assist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems.
• Perform document filing and retrieval functions as directed and per company’s policies and procedures.
• Effectively communicate with internal and external teams and/or clients as to the status of deliverables, to ensure timely and satisfactory completion of tasks and expectations.
• Communicate with the project teams on a regular basis regarding regulatory updates.
• Provide support to internal and external teams to address various technical inquiries and provide requested data/information
• Participate in group meetings and provide tactical approaches to addressing issues of basic complexity