Regulatory Affairs Manager (Medical Device Domain)

☑ Основной блок:

Опыт работы: более 6 лет.

Тип занятости: частичная занятость.

График работы: полный день.

Зарплата: от 2500 до 3500 USD.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 28409812 добавлено в базу данных: Вторник, 28 января 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Репутация компании "MDCE??????????????":

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☑ Подробности о вакантном месте:

A. Company Overview:

MDCE is a prominent Contract Research Organization (CRO) based in China. We are committed to delivering top-notch services, encompassing consultation, clinical trials, and registration, among others, to our clients across diverse sectors such as medical devices, pharmaceuticals, and software projects. Our primary market focus includes the United States, Europe, ASEAN Free Trade Area, Australia, the Middle East, Africa, and the CIS Collective Security Treaty Organization. Our unwavering dedication to quality sets us apart in the industry.

B. Job Summary:

We are seeking a highly skilled and experienced Medical Device Regulatory Consultant to join our team. As a consultant, you will be responsible for providing regulatory guidance and support for registrations process of various medical device in the European, American, Southeast Asia markets. The focus will be on medical devices ranging from Class ? to Class ?.

C. Responsibilities:

1. Conduct in-depth research and analysis of European and American regulatory requirements for medical devices.

2. Stay updated with the latest regulatory changes and ensure compliance with relevant laws and guidelines.

3. Provide strategic advice and guidance to clients regarding regulatory pathways for product registrations.

4. Develop and review technical documentation, including technical files, design dossiers, and regulatory submissions.

5. Assist in the preparation and submission of regulatory applications for market clearance and approvals.

6. Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

7. Prepare and maintain regulatory files, including documentation of product changes, adverse events, and post-market surveillance.

8. Liaise with regulatory authorities and notified bodies to address queries, requests for additional information, and facilitate timely approvals.

9. Monitor and track the progress of regulatory submissions and communicate updates to clients.

10. Participate in the development and improvement of internal processes and procedures related to regulatory affairs.

D. Requirements:

1. Bachelor's degree in a relevant scientific or engineering field.

2. Minimum of 5 years of experience in medical device regulatory affairs, with a focus on European and American markets.

3. In-depth knowledge of European Medical Device Regulation (MDR) and Medical Device Directive (MDD), as well as FDA regulations in the United States.

4. Familiarity with the classification and risk assessment of medical devices (Class ? to Class ?).

5. Proven experience in preparing and submitting regulatory applications for medical device registrations.

6. Strong understanding of the European and American regulatory processes, including the timeline for market clearance and registrations.

7. Excellent communication skills and the ability to effectively collaborate with internal teams and external stakeholders.

8. Detail-oriented with exceptional analytical and problem-solving skills.

9. Ability to work independently and manage multiple projects simultaneously.

If you are a highly motivated professional with a deep understanding of European and American medical device regulations and a passion for ensuring compliance, we invite you to apply for this position. Join our team and contribute to the success of our clients in bringing safe and effective medical devices to the market.

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