Contract Specialist, Regulatory Affairs

About the role

The Contract Specialist, Regulatory Affairs role focuses on customer quality agreements, supplier quality agreements, nondisclosure agreements, and related legal and compliance documents.

Responsibilities

• Draft, review, revise and negotiate: Customer Quality Agreements, Supplier Quality Agreements, Nondisclosure Agreements / Confidentiality Agreements, and Regulatory and quality-related contract clauses, addenda, and amendments.
• Ensure agreements accurately reflect applicable legal, quality, and regulatory obligations, including roles, responsibilities, and escalation pathways.
• Partner with Quality, Regulatory Affairs, Legal, Supply Chain, and Commercial teams to ensure agreements reflect business needs and compliance requirements.
• Coverage of internal stakeholders including Legal, Quality, Regulatory, and Global Supplier Management as needed.
• Identify legal and compliance risks in proposed contract language and recommend revisions to align with company standards and regulatory expectations.
• Maintain contract templates, standard clauses, and agreement records.
• Support the development and standardization of internal processes for contract review, approval, version control, and record retention.
• Track contract status, key obligations, renewal dates, and action items to ensure timely execution and compliance.
• Aid Quality and Regulatory teams with interpretation of contractual commitments and support follow-up actions to ensure obligations are met.
• Support audits, inspections, and internal assessments by providing contract documentation and evidence of agreement control processes.
• Collaborate in the development of training and guidance for internal teams on quality and regulatory contractual requirements.
• Provide general legal/contractual support to Quality and Regulatory teams on special projects, policy updates, and compliance initiatives.
• Escalate complex legal issues to internal legal counsel when appropriate.

Requirements

• Associate’s degree/equivalent education in Business, Legal Studies, Regulatory Affairs, Life Sciences, or related field.
• 5+ years of experience in contract review, drafting, or contract administration.
• Familiarity with quality agreements, supplier agreements, and confidentiality agreements.
• Excellent organizational and prioritization ability.
• Ability to work independently, within a team, and with individuals at all levels.
• Knowledge of contract structure, terminology, and negotiation principles.
• Ability to review and interpret quality and regulatory obligations in commercial and technical agreements.
• Strong written and verbal communication, attention to detail, organization skills, and ability to work across functions.
• Ability to manage multiple agreements and deadlines simultaneously.
• Ability to maintain confidentiality and handle sensitive information appropriately.
• Ability to work cross-functionally with Quality, Regulatory, and Legal teams preferred.
• Familiarity with FDA, ISO, cGMP or quality systems requirements.

Qualifications

• Bachelor’s degree
• Paralegal certification, contract management certification, or equivalent experience preferred
• Experience in a regulated environment, ideally medical devices, life sciences, diagnostics, or biopharma support industries.

Skills

• Experience in a regulated environment, ideally medical devices, life sciences, diagnostics, or biopharma support industries.

Benefits

Corning offers a comprehensive benefits package including:

• Company-wide bonuses and long-term incentives aligned with key business results.
• 100% company-paid pension benefit with fixed contributions that grow throughout your career.
• Matching contributions to your 401(k) savings plan, potentially reaching between 7% and 12% of your pay, depending on your age and years of service.
• Health and well-being benefits such as medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP).
• Recognition program to celebrate successes and reward colleagues who make exceptional contributions.

Pay

The range for this position is $71,252.00 - $97,972.00 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.

Schedule

This position does not support immigration sponsorship.