Associate, Regulatory Affairs (Medical Devices)
ClinChoice, Cincinnati, OH, United States
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!
Key Responsibilities
Manage, plan, prepare, and deliver both electronic and paper-based documents to support global regulatory registrations, renewals, tenders, customs, and related activities
Coordinate the preparation and submission of medical device applications by providing timely and accurate regulatory information and documents, and follow-up closely on queries from inspection through approval
Evaluate documents for accuracy, appropriateness, and consistency for various regulatory submissions
Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, powers of attorney, and other regulatory documents
Perform and/or coordinate legalization, notarization, and apostille of regulatory documents as required
Ensure compliance with current good documentation practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
Submit and manage applications for US FDA Certificates of Foreign Government (CFGs)
Provide support to internal and external teams by addressing technical inquiries and supplying requested regulatory information
Utilize and maintain various systems and/or tracking tools to ensure up to date information and traceability of all regulatory data/documentation
Perform document filing and retrieval in accordance with company policies and procedures
Effectively communicate with various teams and clients regarding the status of deliverables to ensure timely and satisfactory completion of tasks and expectations
Participate in group meetings and provide tactical approaches to addressing issues of basic complexity
Perform other duties as assigned
Qualifications
Bachelor’s degree (Life Sciences or a regulatory related field preferred)
Minimum 1 year of experience in Regulatory Affairs within the medical device industry (regulatory registrations/ submissions preferred)
General knowledge of EU MDD/MDR, US FDA QSR, and ISO 13485 standards
Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint
Strong understanding of Good Documentation Practices (GDP) in a regulatory environment
Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently
Self-motivated and capable of working independently, as well as collaboratively, on projects of diverse scope requiring analytical evaluation of data and situations
Excellent English communication skills, both written and verbal
Detail-oriented with strong critical thinking and analytical abilities, focused on delivering high-quality results
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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.
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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!
Key Responsibilities
Manage, plan, prepare, and deliver both electronic and paper-based documents to support global regulatory registrations, renewals, tenders, customs, and related activities
Coordinate the preparation and submission of medical device applications by providing timely and accurate regulatory information and documents, and follow-up closely on queries from inspection through approval
Evaluate documents for accuracy, appropriateness, and consistency for various regulatory submissions
Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, powers of attorney, and other regulatory documents
Perform and/or coordinate legalization, notarization, and apostille of regulatory documents as required
Ensure compliance with current good documentation practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
Submit and manage applications for US FDA Certificates of Foreign Government (CFGs)
Provide support to internal and external teams by addressing technical inquiries and supplying requested regulatory information
Utilize and maintain various systems and/or tracking tools to ensure up to date information and traceability of all regulatory data/documentation
Perform document filing and retrieval in accordance with company policies and procedures
Effectively communicate with various teams and clients regarding the status of deliverables to ensure timely and satisfactory completion of tasks and expectations
Participate in group meetings and provide tactical approaches to addressing issues of basic complexity
Perform other duties as assigned
Qualifications
Bachelor’s degree (Life Sciences or a regulatory related field preferred)
Minimum 1 year of experience in Regulatory Affairs within the medical device industry (regulatory registrations/ submissions preferred)
General knowledge of EU MDD/MDR, US FDA QSR, and ISO 13485 standards
Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint
Strong understanding of Good Documentation Practices (GDP) in a regulatory environment
Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently
Self-motivated and capable of working independently, as well as collaboratively, on projects of diverse scope requiring analytical evaluation of data and situations
Excellent English communication skills, both written and verbal
Detail-oriented with strong critical thinking and analytical abilities, focused on delivering high-quality results
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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.
#J-18808-Ljbffr