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...
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...
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...
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...
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 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...
Regulatory Affairs Specialist III – Global Submissions. As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc. This is a world-class position where you will collaborate with Regulatory Project Leads to prepare flawless regulatory submissions and ensure their timely delivery to globa...
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. ...
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...
Experience (1-2 years) in a Quality Assurance related role. ...
We are seeking a Program Manager to lead programs for military and government applications. In this role you will direct the development and delivery phase of programs from inception through completion. Program Management as described above. Monitor and manage the program level milestones, risks, is...
PrideStaff is seeking an experienced Project Manager/Estimator in Carlsbad, Ca. Collaborate with project managers, engineers, and subcontractors to gather necessary information for bids. Oversee the estimation process for construction projects from start to finish. Analyze project plans and specific...
If you are interested in applying for this job, please make sure you meet the following requirements as listed below.Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized...
As a WendWell Health Distributor/Agency - Sales Team Manager, you will lead your team of agents dedicated to promoting and enrolling eligible customers into Affordable Care Act (ACA) healthcare plans. Training and Compliance: Conduct comprehensive training programs for new and existing agents, focus...
Whether deployed or in steady state, this position carries out a variety of managerial and supervisory functions including, but not limited to, supervision of personnel assigned to the Planning and Intelligence Section, including implementation, monitoring, and evaluation of work products, and overa...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...
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. ...
Coordinate and assign projects to designers, editors, and external agencies based on project requirements. The ideal candidate is passionate about health and wellness, thrives on managing multiple projects, and enjoys working in a highly collaborative setting. Develop, write, and manage creative bri...
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. ...
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...
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). ...
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
As the Regulatory Affairs Director, you will have the opportunity to lead Allogeneic trials – the most innovative in history! This role allows you to bring past Regulatory knowledge to the table, while also be creative in strategic discussions and decisions. Regulatory Affairs experience within a ph...