職位描述
POSITION SUMMARY
Reporting to the Medical Device Regulatory Manager BD China, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc.
KEYRESPONSIBILITIES
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.…
3. Interact with CFDA on registration requirements and monitor changes to requirements.
4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.
5. Manages a single discipline within the unit on a project or short-term basis.
6. Interacts with manager as required by specific issues, milestones, or status changes.
7. Represents BD externally in long term project in specific fields.
8. Accepts accountability for RA within BD on multi disciplinary platforms.
9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.
10. Ensures compliance with regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.
11. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
SKILLSANDABILITIES
1. Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.
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 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.
6. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.
7. Minimum 2 years of directly related experience in medical device, or pharmaceutical fields, and three or more years of management experience.
8. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.
9. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as technical or subject matter expert in multiple areas.
10. Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.
11. 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.
12. Asserts own ideas and persuades others. Fosters collaboration among team members. Recognized as leader within department.
13. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department.
