职位描述
POSITION SUMMARY
Working closely with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. NMPA Pre-market approval submission & regulatory reporting, cooperating with global RA regulatory and regulatory environment shaping in Medical Device industry. Have post market compliance knowledge and keep a smooth working relationship with related NMPA officials
KEY RESPONSIBILITIES
1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.
2. Acts as the Regulatory partner for the BU he/she is responsible for support regulatory daily request from BU and actively participate registration strategy discussion
3. Interact with NMPA on registration requirements and monitor changes to requirements.
4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.
5. Interacts with manager as required by specific issues, milestones, or status changes.
6. Manages the regulatory review of labels, labeling, promotional materials, handling and cooperating with RC for AE and recall related issues for products that are under his/her responsibilities.
7. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
SKILLS AND ABILITIES
1. Ability to think strategically, to detect the essence of complex or ambiguous issues.
2. Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas.
3. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.
4. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
5. Minimum 5 years working experience in medical device regulatory affairs, experience in IVD will be a plus
6. Demonstrate to have registration experience on multiple, diverse, and or complex product lines.
7. Independently manages and monitors multiple complex and diverse short term and long-term projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.
8. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department.
9. Fluent written and spoken English
DESIRABLE
B.S. or B.A. degree in a technical discipline (bioengineering, microbiology, chemical, biology, pharmaceutical preferred).
