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Regulatory Compliance Specialist
2 months ago
POSITION TITLE: Regulatory Compliance Specialist
REPORTS TO: RA Compliance Manager
FUNCTION: This position responsible for implement Key BCCE PMS pro ject s , make PMS strategy for product line and daily PMS work content (such as Field Action reporting, Adverse event reporting, PRER, P romotional materials review , P roduct labeling and IFU ) related to NMPA registration , progressive regulatory strategies and post-marketing surveillance of medical devices and IVD.
BASIC PURPOSE OF THIS POSITION:
Manage PMS group of product line to solve PMS issues timely both comply with NMPA regulation and Company requirements. Overcome the difficulties in process through extension ideas such as workshop and onsite training program. Participate the process optimize and lead his/her team to execute the changes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:
Provides analysis, counsel, regulatory support, quality assurance, environment, health and safety, facility security and emergency response services, and regulatory and compliance technical training services to the organization focus on post market surveillance area as following:
- Field action (Recall) reporting to NMPA.
- Adverse event reporting to NMPA.
- PRER reporting to NMPA.
- Advertisement review and submit to Shanghai AMR.
- Provide PMS training to relevant customer.
- Develop and Maintain Chinese Label and IFU.
- Handle customer feedback in PMS area (NMPA, Hospital, Distributors, and other departments)
PMS Quality System Management include:
- Deploy procedures related to Post Market Surveillance together with other team members.
- Deploy training related to Post Market Surveillance.
- Participant in audit related with PMS.
Project management include:
- Lead company DBS project related PMS issues like Chinese label improvement.
- Participate in NMPA project workshop.
This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.
WORKING RELATIONSHIPS AND CONTACTS:
- External contacts for this position include NMPA, NMPA ADR center, Shanghai FDA, Shanghai ADR center.
- Internal contacts include headquarter, marketing team, logistic team, application and sales/ service team, HR and Finance to gain support from them to resolve problem and make project forwarding.
SUPERVISION RECEIVED AND GIVEN:
The incumbent of this position is responsible for his/her team's work. Only new work is reviewed before issue, all other work is handled independently, reporting status to manager. Half work requires analysis and use of initiative and independent judgment, but most assignments are specific and well defined.
ESSENTIAL QUALIFICATIONS:
EDUCATION & SKILLS:
- Bachelor's degree or above of medical test, laboratory medicine, medical engineering, chemistry, biology and pharmaceutical or above is preferred.
- Fluent English skills in listening, speaking, reading and writing
WORKING EXPERIENCE:
- More than three years' experience on similar position in this area
FUNCTIONAL COMPETENCIES:
This position also requires:
- Be experienced in regulatory and/or clinical field, be familiar with NMPA and international regulation of medical devices and/or IVD
- Excellent teamwork and interpersonal communication skill
- Positive & take responsibility
- Analysis & Judgment, overcomes potential stumbling blocks to achieve objectives
- Resolves issues and conflicts using effective negotiation, persuasion skills and management tools.
- Strong learning skill to learn relevant PMS professional skill like product risk assessment tools
TRAVEL REQUIREMENTS:
This position may require business traveling in an ordinary situation.
WORK ENVIRONMENT:
This position functions in a general office environment.
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