Medical Device Regulatory Affairs Manager, Anovent Pharmaceuticals (Recruitment Information of Shanghai Anovent Pharmaceutical Co.,)

Anovent Pharmaceuticals is an innovative company which is focusing on the research, development, production and sales of respiratory medicines. As an international pharmaceutical company in respiratory area, Anovent is dedicated to provide affordable respiratory medicines for patients worldwide.

Primary role of medical device regulatory affairs manager is to lead Anovent medical device regulatory affairs (RA) team, provide medical device RA strategies and ensure medical device RA objectives achieved successfully for Anovent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Ø  Develop sound global medical device regulatory strategies for new and modified medical devices, and prepare robust medical device regulatory applications to achieve objectives.

Ø  Review protocols and reports to support medical device regulatory submissions, and assess proposed medical device regulations and communicates new medical device requirements to the organization.

Ø  Review device labeling and marketing materials for compliance with regulatory authorities (FDA, EMA, etc) and applicable regulations.

Ø  Review product and manufacturing changes for compliance with applicable regulations (Change Control).

Ø  Independently interact and build partnerships with regulatory authorities (FDA, EMA, etc).

Ø  Provide medical device regulatory leadership to teams: global strategic input (including all feasible alternatives and associated risks) and driving cross functional alignment with issues that could have regulatory ramifications.

Ø  Provide leadership and guidance (including training) to other members of the medical device RA staff.

Requirements

Ø  Master degree or above in related disciplines.

Ø  2+ years’ regulatory experience in medical device or related areas.

Ø  Generic drug experience highly preferred, especially in US ANDA.

Ø  DPI or inhalation product experience highly preferred.

Ø  Strong knowledge with 510(k) applications, PMA supplements and US Class III device regulations and/or knowledge with EU and other international medical device regulations and submissions.

Ø  Good computer skills.

Ø  Strong ability in English, including listening, speaking, reading and writing.

Ø  Excellent problem-solving skills.

Ø  Strong interpersonal skills, organizational skills and attention to detail.

Ø  Strong communications with ability to effectively communicate at multiple levels in the organization.

Ø  Ability to leverage and/or engage others to accomplish projects.

Ø  Multitasks, prioritizes and meets deadlines in timely manner.

        Contact information

        Anna He     Tel: 13816142073      mail:annahe9999@126.com