Sr. Regulatory Affair Specialist

Requisition Number: 59942

Corning is vital to progress – in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers.

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.

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 for CLS and CPT (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

• 技术specialt学士学位y (Engineering, Chemistry, Biologyor similar field).medical device
• Minimum of 4 years of quality/regulatory experience in the Life Science/ Pharma or Biotechnology industry.

Desired

• Bachelor

Desired Skills

• Previous successful regulatory submissions (FDA 510k, CFDA, CDE etc)
• Direct experience interacting with governmental agencies.
• Experience in cGMPand/or GLP or Drug package
• 与管理和subm所需的技能和经验itting 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 communicationand organization skills required.
• Strong attention to detail andanalytical/problem-solving skills.
• Ability to analyze, assess, and critically evaluate products and markets, and advises business teams on regulatory options.
• Fluent oral/written Englishcommunication skills

• Flexibility; ability to work in a dynamic environment while managingmultiple priorities.
• High sense of urgency.