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Company Profile
Career Vision`s Client – CV2012052209
Company profile: Out client is an advanced technology, services and finance company that is built to meet essential world needs.
Company size: N/A
Company address: N/A
Job Detail
Job id: JO2012193
Job title: Regulatory Affairs Leader
Job description: Essential Responsibilities:

- Ensure accurate and optimal presentation of regulatory submissions that meet current best practice standards

- Provide input into submission planning and work to agreed timelines

- Liaise with relevant personnel to ensure appropriate, timely input is provided for submissions

- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions, product complaint risk assessments, adverse event reporting and product field actions through the development, maintenance and improvement of documented processes

- Support Regulatory deliverables including, but not limited to:
 + Regulatory Site Registrations
 + Product Listing
 + Product Licensing
 + Product Regulatory Submissions (e.g., Vietnam submissions)
 + Adverse event reporting
 + Recall reporting

- Support continuous improvement activities with regard to areas of responsibility

- Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility

- Identify regulatory trends and their implications for the company; Develop & implement effective regulatory strategies to meet business objectives

- Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met

- Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility

- Educate, train, & advise company professionals to ensure compliance with RA requirements

- Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety

- Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight

- Support continuous improvement activities with regard to areas of responsibility

- Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility

Quality Specific Goals:

- Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

- Complete all planned Quality & Compliance training within the defined deadlines

- Identify and report any quality or compliance concerns and take immediate corrective action as required

- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility

- Effectively support implementation & management of current regulatory requirements within area of responsibility

- Ensure assigned regulatory submissions are accurate, complete and timely

  Job Requirement
General: Years of experience: At least 2 years
  Minimum career level: Team Leader/Supervisor
  Minimum education level: Bachelors
  Minimum language: English - Level: Advanced
  General request: Qualifications/Requirements:

- Bachelor's Degree in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy

- Strong analytical skills

- Ability to work with minimal supervision on projects and activities

- Ability to prioritize, plan & evaluate deliverables

- Knowledge & experience conducting scientific, regulatory, legal, or business research.

- Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner

- Prior experience using spreadsheet and presentation software

Desired Characteristics:

- Experience in a medical device or pharmaceutical industry

- Knowledge of Quality Management Systems (QMS)

- Ability to work across cultures

- Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations

- Team-oriented and responsive to customer needs.

- Familiar with continuous improvement methodologies such as Lean & Six Sigma

  Computer skills: N/A
  Soft skills: N/A
  Other skills: N/A
  General Information
Job Type: Full-Time Permanent
Location: Hà Nội
Job category: Heath/Medical Care
  Human Resources
Job level: Team Leader/Supervisor
Salary: Negotiable
Benefit: N/A
Contact: Applicants please send us your CV to this email

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