A company is looking for a Senior Regulatory Affairs Specialist (Remote/Flexible). ...
Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regula...
Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance, authors and maintains material compliance certifications, and responds to internal and external customer and/or agency regulatory requests. Specialist, Regulatory Affairs, Product Stewardship. Department: Regul...
The Regulatory Affairs Start-Up Specialist is expected to resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation. Ophthalm...
Implement all regulatory activities according to in-house procedures and regulatory requirements. Facilitate daily regulatory affairs activities under the guidance of the RA/QA manager. Communicate with regulatory agencies; provide support to ensure that the company is 100% compliant with US and int...
Reviews the preparation of document packages for regulatory submissions to ensure compliance with local and regional registration requirements. Drives changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regulatory procedures and changes. L...
Principal Regulatory Affairs Specialist,. Principal Regulatory Affairs Specialist,. This position requires extensive expertise in regulatory frameworks, strategic planning, and cross-functional collaboration to ensure timely regulatory approvals and compliance with international standards. Contribut...
A global leader in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. The Regulatory Affairs Specialist should have the following qualifications:. Responsibilities of the Regulatory Affairs Specialist include...
A global leader in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. The Regulatory Affairs Specialist should have the following qualifications:. Responsibilities of the Regulatory Affairs Specialist include...
Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regula...
Regulatory Affairs Specialist Responsibilities:. Regulatory Affairs Specialist. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regulatory procedures and changes. ...
The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections for U. Principal Regulatory Affairs Specialist. Principal Regulatory Affairs Specialist (Pittsburgh, PA or Cambridge, MA). You've acq...
Implement all regulatory activities according to in-house procedures and regulatory requirements. Facilitate daily regulatory affairs activities under the guidance of the RA/QA manager. Communicate with regulatory agencies; provide support to ensure that the company is 100% compliant with US and int...
Regulatory Affairs Specialist Job Responsibilities:. Regulatory Affairs Specialist Qualifications:. Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices;. Obtains and reviews clinical study data with Clinical Data Manag...
The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply tea...
Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance, authors and maintains material compliance certifications, and responds to internal and external customer and/or agency regulatory requests. Specialist ensures timely and high-quality execution of all regulatory...
Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regula...
Related duties include participation on design teams authoring of regulatory assessments for both new products and product modifications documentation of regulatory impact from device modifications establishment and maintenance of Technical Files labeling I advertising review and other regulatory wo...
Related duties include participation on design teams authoring of regulatory assessments for both new products and product modifications documentation of regulatory impact from device modifications establishment and maintenance of Technical Files labeling I advertising review and other regulatory wo...
The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections for U. Principal Regulatory Affairs Specialist. Principal Regulatory Affairs Specialist (Pittsburgh, PA or Cambridge, MA). You've acq...
Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and dev...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Principal Regulatory Affairs Specialist,. Principal Regulatory Affairs Specialist,. This position requires extensive expertise in regulatory frameworks, strategic planning, and cross-functional collaboration to ensure timely regulatory approvals and compliance with international standards. Mentor ju...
Reviews the preparation of document packages for regulatory submissions to ensure compliance with local and regional registration requirements. Drives changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps abreast of regulatory procedures and changes. L...