Regulatory Affairs Specialist - Remote

Requisition Number: 63008

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.

Scope of Position: Regulatory Affairs Specialist provides necessary support to regulatory affairs department in many areas including new product review, regulatory filings, promotional material review, label review, knowledge of regulations, standards, regulatory policies and procedures, customer enquiries, Product Stewardship including conflict minerals reporting, export/import requirements, post market review & assessment and training.

THIS POSITION CAN BE REMOTE OR LOCATED IN CORNING, NY/TEWKSBURY, MA/KENNEBUNK, ME/DURHAM, NC

Key Responsibilities:

• Coordinate efforts associated with the preparation of regulatory documents or submissions for domestic and international projects
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
• Compile and prepare documents for Drug Master File (DMF)/ Master File (MFs) submission for different regions across the globe
• eCTD technical, formatting and publishing knowledge for regulatory agency submission
• Review electrical equipment standards and advise on applicability as necessary
• Create or update SOPs in response to changes in regulations or standards
• Provide support for maintaining technical files as necessary
• Review product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies
• Compile and maintain regulatory documentation databases or systems (Ex. UDI)
• Maintain list of medical devices and GUDID database for US UDI
• Maintain facility FDA registrations and update as required
• Participate in internal or external audits
• Develop and/or conduct employee regulatory training
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
• Analyze product complaints and perform activities for MDR and Vigilance
• Coordinate recall or market withdrawal activities as necessary
• Review product post market data and file all related reports

Knowledge, Skills, and Abilities:

• Ability to work across matrix organizations and external consultants
• Excellent communication and organization skills required
• eCTD technical knowledge preferred
• Experience with chemical hazard assessments and SDS preferred
• Strong attention to detail and analytical/problem-solving skills
• Ability to analyze, assess, and critically evaluate products and markets
• Demonstrable Project management skills

Education & Experience:

• Bachelor’s degree in Regulatory Affairs, Biological Sciences or Engineering and minimum of 1 year of experience in regulatory affairs for ISO registered products (prefer medical device or pharmaceutical background)
• Master’s degree in Regulatory Affairs, Biological Sciences or Engineering (Preferred)

This position does not support immigration sponsorship.

The range for this position is $62,764.00 - $86,301.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

Corning Puts YOU First!

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.

• Our monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues’ contributions.
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career.
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.
• Professional development programs help you grow and achieve your career goals.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To request an accommodation, please contact us at accommodations@corning.com.

Nearest Major Market: Boston