- Kelly Services (Malvern, PA)
- …optimization and revalidation efforts. + Serve as a SME during internal and external regulatory audits including FDA , EMA . + Extract process data from SCADA ... to assist with change control, equipment startup, and technical training, assuring regulatory compliance and technical feasibility of proposed changes. + Serve as… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …Pittsburg is required. NO relocation assistance. **Key Responsibilities** + As a Regulatory Affairs Specialist II, you will be responsible for the following tasks: ... + Participate in all aspects of the regulatory function, including reviewing items/products for onboarding, addressing specific product inquiries, and tracking… more
- United Therapeutics (Harrisburg, PA)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...senior level employees **Preferred Qualifications** + Proficient knowledge of FDA regulations, including 21 CFR 1271 and 21 CFR… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Philips (New Kensington, PA)
- …and issue resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage ... teams, ensuring alignment with strategic business objectives. + Coordinate with Quality, Regulatory , R&D, Operations, and Marketing teams to meet goals related to… more
- Insight Global (Philadelphia, PA)
- …acquisition, installation, preventive maintenance, and decommissioning. - Ensure compliance with regulatory standards (eg, FDA , Joint Commission, NFPA). - ... and systems, including diagnostic, therapeutic, and life-support equipment. -Expertise in regulatory compliance (eg, FDA , Joint Commission, NFPA, CMS).… more
- Community Health Systems (Dunmore, PA)
- …treatment of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment ... positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability… more
- Canon USA & Affiliates (Harrisburg, PA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and… more
- West Pharmaceutical Services (Exton, PA)
- …+ 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title 21CFR820), EU MDD ... Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746...Date: Aug 8, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **This is a hybrid role(3 days… more
- Merck (Philadelphia, PA)
- …Director, Portfolio & Program Management (PPM)** The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive ... execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for… more