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...
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. ...
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...
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...
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 ...
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:. ...
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...
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. ...
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...
PURPOSE OF POSITIONThe Southern California Regional Rail Authority (SCRRA), operator of the METROLINK Commuter Rail System, is seeking a Senior Manager, Project Management who will provide leadership and oversight for day-to-day management of the Project Management functions for the Southern Califor...
Oversee project activities as assigned by the Project Manager, including planning, coordinating, circumventing/resolving problem areas, ensuring all company/project policies, procedures, and standards are maintained, etc. The Assistant Project Manager is an entry-level project management position an...
Quality Assurance Specialist IV. Quality Assurance Specialist IV:. Quality Assurance Specialist IV:. Provide technical writing in support of operational functions, such as Quality Control (QC). ...
Requirements / Qualifications .Letter(s) of Recommendation (Three (3) required.Two (2) may be personal (non-relative), One (1) must be from current or past employer/supervisor....
Job Location: Rancho Cucamonga, CA (3 days in a week).Coordinate with the stakeholders and resources to ensure alignment of project deliverables and timelines.Ensure successful execution and migration of the project.Health Insurance domain is plus....
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Produce regular reports necessary for Project compliance for IRA and DOL Compliance. Quickly respond to and resolve any non-conformities identified within the project site based on guidance from Compliance Specialist. Monitor apprenticeship program metrics for a project site to ensure 100% complianc...
Director of Regulatory Affairs. Represent Regulatory Affairs in cross-functional development teams and ensure alignment with regulatory requirements. As the global regulatory lead (GRL), you will work cross-functionally with teams to manage regulatory submissions and approvals, ensuring compliance w...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
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...
The ideal candidate will be responsible for overseeing the successful delivery of Oracle ERP/EBS projects ensuring they are completed on time within scope and on budget. Develop and manage project plans timelines budgets and resources to meet objectives. Collaborate with stakeholders to define proje...