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Asia Regulatory Affairs Specialsit

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Date: May 3, 2019

Location: WuJiang, China, CN

Company: Corning

Requisition Number: 36571

 

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Position Description

Purpose of the Position:

 

  • Supports Asia business quality function in many areas including Asia new product review, regulatory filings, promotional material review, label review, regulation research & interpretation, regulatory projects, response to regulators, regulatory procedures, customer inquiries, post market review and other activities as required.
  • Works with division regulatory team to ensure products meet necessary registration or approval from the local or international health authority.

 

Day to Day Responsibilities:

  • Coordinate, prepare or maintain regulatory filings or submissions to obtain and sustain product approval (Establishment registration/device listing, etc). 
  • Develop regulatory plans and strategies for assigned products
  • Document and maintain regulatory procedures, work instructions, or policies for Asia area. Recommend changes to procedures in response to changes in regulations or standards.
  • Review promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Support regulatory related projects (UDI, EU MDR/IVDR, LVD, EMC).
  • Conduct New Product Review using SharePoint based system.
  • Participate on new product project teams and provide inputs for premarket regulatory requirements, labeling requirements, or clinical study.
  • Review proposed product or manufacturing changes for regulatory impacts.
  • Interpret regulations or regulation changes, communicate information cross-functionally and updated in division procedures.
  • Stay updated on existing and changing regulations, standards, or guidance documents. Distribute information on domestic or international laws, guidelines, or standards.
  • Support external audit related to regulatory ( eg : NMPA )
  • Research and interpret regulations to apply to appropriate product lines.
  • Prepare and support responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Support post-market surveillance, vigilance, field action and other activities.
  • Develop, track and maintain metrics
  • Support interactions and communications with health authorities, regulatory bodies, and customer requests.
  • Develop and conduct employee training on regulatory affairs topics.
  • Compile and maintain regulatory documentation databases or systems.
  • Work with Division regulatory team to ensure Asia area regulatory compliance.
  • Other Duties as assigned.

     

     

Education & Experience

Required

  • Bachelor’s degree in technical specialty (Engineering, Chemistry, Biology or similar field).
  • Minimum of 4 years of quality/regulatory experience in the Life Science/ Pharma or Biotechnology industry.

 

 

Desired Skills

  • Previous successful regulatory submissions (FDA 510k, CFDA etc)
  • Direct experience interacting with governmental agencies.
  • Experience in cGMP and/or GLP.
  • Desired skills & experience with managing and submitting regulatory dossier/applications
  • Experience with regulations related to medical device, IVD, or biopharma products
  • Experience with FDA 21 CFR 820, ISO 13485, ISO 9001, or 21 CFR 211/210
  • Experience with electronic document management systems (EtQ or similar)

 

Soft Skills

  • Ability to work across matrix organizations.
  • Excellent communication and organization skills required.
  • Strong attention to detail and analytical/problem-solving skills.
  • Ability to analyze, assess, and critically evaluate products and markets, and advises business teams on regulatory options.
  • Fluent oral/written English communication skills
  • Flexibility; ability to work in a dynamic environment while managing multiple priorities.
  • High sense of urgency.