Director of Regulatory Affairs (Medical Device)

About us:

MDCE is a Global CRO supporting the International Expansion of MedTech Companies Worldwide. Relying on Harvard University's global medical research resources and academic influence, it builds a full overseas service industry chain and provides customized overseas solutions for Biopharmaceutical and Medical Device companies. The core services include Global Clinical Trials, Regulatory Affairs, and Business Consulting.

Job Description:

We are looking for a Regulatory Affairs Manager/Director with strong English language proficiency (Mandarin language knowledge is a plus) to join our team in China. This position will be responsible for the regulatory affairs of high-class medical devices in overseas markets.

Location: SUZHOU, JIANGSU, CHINA

Job Type: Full-Time

Job Responsibilities:

1. Responsible for the registration and declaration of clients' medical products in overseas markets, ensuring the progress and quality of registration.

2. Prepare and implement overseas registration strategies to ensure compliance with regulatory requirements of qualified countries.

3. Work with cross-departmental teams, including clinical and quality assurance departments, to ensure that registration work is consistent with company strategy.

4. Lead and manage the overseas registration team to ensure the continuous development and optimization of team members in terms of professional skills, work efficiency and goal achievement.

5. Provide regulatory strategy advice to senior management of the company to help evaluate the compliance of new and existing products in international markets.

6. Responsible for supervising and tracking changes in industry regulations, and timely adjusting registration strategies to ensure that products meet the latest regulatory requirements of various markets.

The above descriptions are intended to describe the general nature and level of work being performed by incumbents. Incumbents may perform other duties as assigned.

Qualifications:

1. Bachelor's degree in Life Sciences, Pharmacy, or related field (Postgraduate Degree preferred)

2. At least 10 years of experience in the international regulatory affairs field of medical devices.

3. Experience in international registration of high-class medical devices (North America, Europe, etc).

4. Line management and leadership experience.

5. Intercultural ability.