Strategist, Regulatory Affairs

ClinChoice•Cincinnati, OH

52d•Hybrid

About The Position

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 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!

Requirements

Bachelor’s degree (Life Sciences or a regulatory related field preferred)
Minimum of 1 year of hands-on experience in medical device regulatory affairs, or at least 3 years of combined regulatory affairs and related experience.
Basic knowledge of US FDA QSR, ISO 13485, EU MDD/MDR.
Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
Have a good understanding of current Good Documentation Practices in a regulatory environment.
Self-starter with the ability to work in a team environment and on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.
Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently.
Must possess excellent written and verbal communication skills.

Nice To Haves

Knowledge of global medical devices registration process is a plus

Responsibilities

Managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned global regulatory product registrations, renewals, tenders/customs, etc.
Coordinating the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval.
Preparing and/or reviewing 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.
Submitting and managing applications for the US FDA Certificates to Foreign Government (CFGs).
Maintaining various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation.
Performing and/or coordinating legalization, notarization, and apostille of regulatory documents.
Ensuring compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping.
Assisting all regions in answering inquiries and providing required documents and information utilizing various search tools and systems.
Performing document filing and retrieval functions as directed and per company’s policies and procedures.
Effectively communicating with internal and external teams and/or clients as to the status of deliverables, to ensure timely and satisfactory completion of tasks and expectations.
Communicating with the project teams on a regular basis regarding regulatory updates.
Providing support to internal and external teams to address various technical inquiries and provide requested data/information.
Participating in group meetings and providing tactical approaches to addressing issues of basic complexity.
Performing other tasks as assigned.