Regulatory Manager, 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 an experienced Regulatory Manager to work with one of our Consumer Health partners with a focus on Medical Devices. The Regulatory Manager will play a crucial role in ensuring medical devices including substance-based devices combination products and measuring devices meet EU regulation requirements. It will involve travel to Dusseldorf once per month for training and previous experience supporting ISO audits.

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 counterparts. This is a 6-month to 1 year contract and you are required to travel to Dusseldorf for training once a month.

Main Job Tasks and Responsibilities:

• Ensure all medical devices comply with EU regulations including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

• Provide support for ISO audits ensuring compliance with ISO 13485 and other relevant standards.

• Prepare and maintain regulatory documentation including Technical Files and Design Dossiers.

• Manager regulatory submissions and compliance for substance-based devices ensuring they meet all necessary requirements.

• Manage regulatory submissions and compliance for combination products.

• Ensure regulatory compliance for medical measuring devices.

• Work closely with R&D manufacturing and quality assurance teams to provide regulatory guidance throughout the product development and lifecycle processes.

• Monitor changes in medical device regulations and standards and update internal teams accordingly.

• Provide training and support to internal teams on regulatory requirements and best practices.

Education Experience and Skills:

• University Degree in a scientific or engineering discipline such as Biomedical Engineering Chemistry Biology or a related field. Advanced degree preferred.

• Minimum of 5-7 years of experience in regulatory affairs within the medical device industry.

• In-depth understanding of EU medical device regulations and guidelines. Experience with substance-based devices combination products and measuring devices is essential.

• Proven experience in supporting ISO 13485 audits and ensuring compliance.

• Strong analytical and problem-solving skills.

• Excellent communication and interpersonal skills.

• Ability to work effectively in a team environment.

• Exceptional attention to detail and organisational skills.

• Proficiency in English and German is required.

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 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.

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