Strategist, Regulatory Affairs (Medical Devices)

Location: Raritan, NJ (HYBRID)

Schedule: Permanent- FTE

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 Strategist, Regulatory Affairs in HYBRID model at Raritan, NJ on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.

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

 

Main Job Tasks and Responsibilities:

Primary Responsibilities:

•    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
•    Responsible for preparation and/or review of letters of authorizations, cover letters for registration certificates, declarations, power of attorney, etc., to ensure accuracy, appropriateness and consistency of documents intended for various regulatory submissions
•    Perform and/or coordinate legalization, notary and apostille of regulatory documents
•    Ensure compliance with current good documentation practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
•    Assist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems
•    Maintain various tracking tools to ensure up to date information and traceability of regulatory and project related data/information 
•    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
•    Provide support to internal and external teams to address various technical inquiries and provide requested data/information
•    Perform other regulatory or project-related duties as assigned.

Experience/Skills

•    Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; advanced degree preferred 
•    Minimum of 2 years of Regulatory Affairs experience in medical device industry 
•    Strong knowledge of US FDA regulations (21 CFR), ISO13485 and EU MDR is required.
•    Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
•    Have good understanding of current Good Documentation Practices in regulatory environment 
•    Detail-oriented, highly organized, and capable of managing multiple priorities.
•    Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
•    Must possess excellent written and verbal communication skills
•    Detail oriented with strong critical thinking and analytical skills and keen on producing results
•    RAC and/or PMP certification is a plus.

 

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. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

 

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 to 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.

 

Key words: Regulatory Affairs, medical devices, EU MDR, product registrations. 

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