Strategist, Regulatory Affairs

ClinChoice; Cincinnati (OH); Hybrid; USD 60,000 - 85,000; Full time

Job summary

ClinChoice is seeking an Associate, Regulatory Affairs for a hybrid role in Cincinnati, OH. The candidate will manage regulatory documents, submissions, and communications across global registrations, ensuring accuracy and timely delivery.

Requirements include a Life Sciences degree and 1 year in medical device regulatory affairs (or 3 years RA/related experience), knowledge of FDA QSR, ISO 13485, EU MDR, and strong documentation skills. Proficiency in Microsoft Office is essential.

Qualifications

• Bachelor’s degree in Life Sciences or regulatory field preferred.
• 1 year regulatory affairs experience or 3 years combined RA experience.
• Knowledge of US FDA QSR, ISO 13485, EU MDD/MDR.
• Proficient in Microsoft Office and strong documentation practices.
• Self-starter able to work in a team with minimal supervision.
• Excellent organizational and communication skills.

Responsibilities

• Manage, prepare, and deliver regulatory documents for global submissions.
• Coordinate preparation and submission of medical device applications and respond to queries.
• Prepare authorization letters, cover letters, declarations and power of attorney.
• Submit and manage US FDA CFGs.
• Maintain tracking tools for regulatory data and documentation.
• Coordinate legalization, notarization, and apostille of documents.
• Ensure compliance with documentation practices and recordkeeping.
• Communicate with internal/external teams on deliverables and status.

Skills

Regulatory affairs

FDA QSR knowledge

ISO 13485

Attention to detail

Education

Bachelor’s degree in Life Sciences or regulatory field

Tools

Microsoft Office

Job description

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!

J** ob Title:** Strategist, Regulatory Affairs

Employment Type:

Full Time

Location:

Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek RdBlue 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
• Perform other tasks as assigned.

Experience/Skills

• 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.
• Knowledge of global medical devices registration process is a plus
• 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.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-PB1 #Hybrid