Responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets. Regulatory Operations within the medical device industry. Understanding of US and EU medical device regulations, including submiss...
As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Exercise judgme...
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...
Seniro Regulatory Affairs Specialist. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regul...
In Vitro Diagnostic Regulatory Specialist (R&D/QA). Regulatory affairs, in Quality Assurance, R&D, Manufacturing or Project Management in IVDR (Vitro Diagnostic Regulation). ...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training progra...
As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved ...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...
The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for SkinMedica products. With supervision, the specialist reviews, plans and prepares regulatory documents and labelling for cosmetic or OTC product registrations/updates. With supervision...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. As a key player in regulatory oversight, you will help ensure product compliance with global regulatory standards, including ISO 13485 and FDA regulations. ...
Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company-Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced-Technical wri...
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...
The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for company products. Reviews, plans, and prepares regulatory documents and labelling for cosmetic or OTC product registrations/updates. Reviews product labeling for accuracy and for other...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and rep...
He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Prin Regulatory Affairs Specialist. Sustaining regulatory responsibilities include reviewing changes to ensure that regulato...
The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for company products. The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Specialist - Skincare for a prominent Pharmaceutical client of ours. Re...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...