A company is looking for a Regulatory Affairs Specialist I to manage regulatory documentation and submissions. ...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a. Principal Biologist/Regulatory Specialist,. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
A company is looking for a Regulatory Compliance Specialist 4 to support and implement audit programs for cloud infrastructure. ...
Seeking a Senior Regulatory Affairs Specialist with expertise in US and EU regulatory requirements, EU MDR regulation, and medical device regulatory submissions to sustain the current product portfolio. Partner with the international regulatory affairs group to support regulatory submissions. In-dep...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
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...
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...
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 ...
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...
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...
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. ...
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...
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. Regulatory Compliance - knowledge of federal and municipal regulatio...
Thorough knowledge of policies, practices and procedures related to Regulatory Affairs. ...
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...
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...
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...
Program and Regulatory Specialist. The Energy Commission seeks a Program and Regulatory Specialist to fill one position in the Special Projects Unit within the Fuels and Transportation Division. Under general direction of a Program and Project Supervisor, the Program and Regulatory Specialist will s...
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 ...
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional no...
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...
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...
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:. ...
Work closely with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to gather information and ensure that all of regulatory documentation for new products, changes to existing products, and post-market activities are compliant. Assist with the preparation and timely sub...