Regulatory Affairs Associate Consultant - Medical Devices

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

This position is open to candidates who have a minimum of three years of hands-on experience in local medical device regulations and have a basic overall understanding of EU MDR medical device regulations and requirements. This position requires a strong team player who can work across various cultures and departments to meet team company and client goals and assigned objectives.

Job Duties:

• Responsible for post market support for local medical device registrations.

• Responsible for the documents review of product changes due to EU MDR impact and the management of any required submissions.

• 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.

• Extract available documents from the document management database and operational systems to assist in the preparation of the dossiers.

• Ensure compliance with current good documentation (cGDP) practices including but not limited to proof reading formatting indexing record keeping etc.

• Assist team members 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 all regulatory data/documentation.

• 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.

• Provide support to internal and external teams to address various technical inquiries and provide requested information.

• Participate in group meetings and provide tactical approaches to addressing issues of basic complexity.

• Work with relevant cross functional teams to collect the required documents.

Education and Experience:

• Minimum of three years of working experience in regulatory affairs in preparing and reviewing technical documentation and submissions per local regulations.

• Basic knowledge of US FDA QSR ISO13485 EU MDD/MDR or equivalent education is preferred.

• Proficient in Microsoft Office (e.g. Word Excel PowerPoint).

• Fluency in local language and English

• Have good understanding of current Good Documentation Practices in regulatory environment.

• Strong organizational skills including attention to detail good planning and communication skills are required.

• 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.

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 4000 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.

Key words: Regulator Affairs Regulatory Compliance Regulatory Submission ISO 13485 EU MDD/MDR

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