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 Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
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 ...
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 ...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
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...
Minimum two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry. ...
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 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...
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 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 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...
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 ...
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...
Bachelor’s degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. ...
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:. ...
ESI) seeks an experienced Associate General Counsel to serve the needs of our rapidly expanding client base across the United States. Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks. The Associate General Counsel position provi...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...
Project Managers (levels I, II, and/or III). Licensed professional or Certified Construction Manager (CCM) or PMP. Work experience in project planning and development. Ability to independently manage all aspects of a project. ...
Under the general direction of the Project Manager – Reports of Investigation (“ROI”) and the Utilities Senior Project Manager, the Utility Design Reviewer contributes alongside a team of Utility Design Reviewers to prepare, review, coordinate, and track all utility Reports of Investigation for the ...
Account Executive / Project Manager. As an Account Executive / Project Manager, you will report directly to the Account Director and collaborate with cross-functional teams to ensure successful campaign execution across various brand touch points. Account Executive / Project Manager. Serve as primar...
Quality Assurance (QA) Analyst II. Quality Assurance certifications, preferably. A minimum of three (3) years of advanced Quality Assurance experience. Creating and effectively executing test planning, manual test case authoring, scripting of automated tests, test execution, defect management, testi...
They're looking for a driven Senior Trade Compliance Specialist who will oversee site export and import compliance programs. Benefits of the Senior Trade Compliance Specialist:. Primary Responsibilities of the Senior Trade Compliance Specialist. Qualifications of the Senior Trade Compliance Speciali...
Were seeking a skilled Cybersecurity Compliance Analyst to join our client in a remote capacity. The ideal candidate will have a strong background in compliance programs cybersecurity and clientfacing roles within a Managed Service Provider (MSP) environment. Manage compliance programs with a focus ...
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...