Contract Specialist, Regulatory Affairs

Corning•Tewksbury, MA

7d•$71,252 - $97,972•Onsite

About The Position

As the Contract Specialist, Regulatory Affairs, this role focuses on customer quality agreements, nondisclosure agreements, supplier quality agreements, and related legal and compliance documents. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible. With our people, they break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. Corning’s businesses are ever-evolving to best serve our customers, industries, and consumers. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets. We are changing the world with trusted products that accelerate drug discovery, development, and delivery to save lives; damage-resistant cover glass to enhance the devices that keep us connected; optical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of light; precision glass for advanced displays to deliver richer experiences; auto glass and ceramics to drive cleaner, safer, and smarter transportation; and solar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutions.

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.

Nice To Haves

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.

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.
Coordinate contract review with 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.
Assist 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.
Collaborate with cross-functional teams, to obtain information for critical agreement needs.
Monitor and adapt to changes in industry standards and regulations to ensure ongoing compliance and competitiveness.