What are the responsibilities and job description for the Regulatory Affairs Manager position at e&e IT Consulting Services, Inc.?
e&e is seeking a Regulatory Affairs Manager for a hybrid contract opportunity in Pittsburgh, PA!
The Regulatory Affairs Manager will play a key role within a newly structured Global R&D Compliance organization, supporting continued growth and expanding regulatory responsibilities across domestic and international markets. This position is responsible for managing regulatory approvals, leading compliance-related initiatives, and ensuring products meet all applicable regulatory requirements throughout their lifecycle. The role partners closely with cross-functional teams, suppliers, customers, legal counsel, and regulatory agencies to maintain compliance and drive continuous improvement in regulatory processes.
Responsibilities:
- Manage regulatory approval processes for products across applicable domestic and international markets.
- Establish, lead, and track regulatory and compliance-related projects, ensuring timelines and deliverables are met.
- Interpret and apply regulatory requirements to product development, change management, and lifecycle activities.
- Collaborate closely with internal stakeholders including R&D, Quality, Legal, Supply Chain, and Operations.
- Serve as a primary regulatory point of contact for suppliers, customers, and external regulatory agencies.
- Support regulatory audits, submissions, and the preparation and maintenance of compliance documentation.
- Ensure regulatory and compliance activities align with corporate policies, industry standards, and applicable regulations.
- Contribute to the continuous improvement of regulatory processes, tools, and systems.
Qualifications & Requirements
- Bachelor’s degree in Engineering, Materials Science, Chemistry, or a related technical discipline.
- Approximately 5 years of experience in Regulatory Affairs or a closely related regulatory/compliance role.
- Strong understanding of regulatory approval processes and compliance frameworks.
- Quality or compliance background strongly preferred.
- Project management experience is a plus.
- Experience working cross-functionally with internal legal teams and external regulatory agencies.
- Excellent organizational, communication, and stakeholder management skills.
No C2C