職位描述
職位描述：
法規事務高級專員-蘇州
Working closely with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA/CE Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, and contribute to the post market surveillance actively， support product registration in overseas countries.
KEY RESPONSIBILITIES
1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.
2. Interact with CFDA on registration requirements and monitor changes to requirements.
3. Independently manages and provide regulatory guidance to multiple long-term projects under supervision.
4. Manages a single discipline within the unit on a project or short-term basis.
5. Interacts with manager as required by specific issues, milestones, or status changes.
6. Represents BD externally in long term project in specific fields under the instruction of manger.
7. Accepts accountability for RA within BD on multi-disciplinary platforms.
8. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.
9. Ensures compliance with China regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.
10. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
11. Actively contribute to the post market surveillance issues on related responsible product line
SKILLS AND ABILITIES
1. Sense to think strategically, to detect the essence of complex or ambiguous issues, and report to manager.
2. Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and regions, particularly with regulators and Standard committee members. Independently authors written reports/documents for distribution within division.
3. 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. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues under the guidance of manger and provide input towards suitable actions.
4. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers.
5. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
1-2 years working experience in medical device regulatory affairs
8. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.
9. Demonstrates understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes.
10. Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan in the scope of his/ her responsibilities.
11. Manages and monitors multiple complex and diverse short term and long-term projects with direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.
12. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department.
DESIRABLE
B.S. or B.A. degree in a technical discipline (bioengineering, microbiology, chemical, biology, pharmaceutical preferred). With Degree abroad best.
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