QA/ra Associate Specialist

2 weeks ago

Singapore Zimmer Biomet Full time

-Requisition Number
APAC05208
Employment Type
Full-time
Location
Singapore

**Job Summary**:
**Principal Duties and Responsibilities**:

- Regulatory Affairs- Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives.
- Define and implement product registration approval strategies and plans.
- Manage product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses.
- Update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.

Regulatory Operations- Maintain a 12-month regulatory plans, renewals and new submissions
- Maintain databases of all submissions and approvals.
- Support internal systems and processes, relating to regulatory and quality, e.g. International Registration Requests (IRR), Change Notifications, SAP, GTS
- Oversee and ensure development, implementation and compliance of relevant SOPs and execute regulatory operations such as Global Distribution Regulatory Controls and Regulatory Information Management System

Regulatory Compliance- Oversee copy review advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations.
- Responsible for adverse event and field safety corrective action/ product recall reporting and timely closure with the regulatory authority.
- Manage the implementation of Good Distribution Practices for Medical Device (GDPMD).

New and Changing Regulatory Environment- Understand and help influence medical device regulatory environments by leveraging key relationships with the Authority and with industry groups.
- Proactively work with the government officials and other agencies in resolving pre and post-market registration issues.
- Provide assessment of the new and changing regulations for any impact. Outline the plan for mitigation of impact, communicate to stakeholders and implement.

Quality- Manage Internal and External Audits such as CAB (Conformity Assessment Body).
- Assist QA in the management of product complaints and execution of field safety correction action and related activities.
- Manage the SOP, WI and the overall QMS (Quality Management System) of the organization.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions".**Expected Areas of Competence**:

- Business proficiency in spoken and written English
- Superior interpersonal and communication skills
- Responsible, professional, detail oriented and with patience
- Strong computer skills (MS Excel)
- Ability to work and partner with both internal and external stakeholders.
- Ability to manage multiple projects and registrations.

**Education/Experience Requirements**:

- Bachelor’s Degree in life sciences, technical (engineering) or related field; advanced degree strongly preferred.
- Minimum of 2 years of experience required in a Regulatory Affairs capacity.
- Experience in the areas of medical devices, drugs, biologics, and combination products regulations is strongly preferred.
- A combination of education and experience may be considered.

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