A company is looking for a Senior Regulatory Specialist to support product compliance strategies and ensure regulatory standards are met. ...
Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and...
A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
The Regulatory Affairs Specialist will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. Senior Regulatory Affairs Specialist (Locals Only with experience composing submissions...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Experience with Japanese and Chinese regulatory submissions. Ability to interpret and apply regulatory requir...
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 Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. Job Title: Regulatory & Compliance Specialist. Support preparation of internal ...
Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc. Previous APAC regulatory experience in the medical device or pharmaceutical industries. ...
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
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...
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 ...
The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. Regulatory Affairs Specialist I. Drafts, edits and compiles technical documentation ...
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...
Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory strategy or product portfolio. Accountable for supporting...
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...
The Staff Regulatory Specialist performs product registrations and act as the company representative with the applicable regulatory authorities. The Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. The Staff Regulatory Specialist advises on the implemen...
Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance. Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), includ...
Our Toxicology business unit has an opportunity for a Regulatory Affairs Specialist II which can be based in either San Diego, CA or Pomona, CA. This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distrib...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. Job Title: Regulatory & Compliance Specialist. Support preparation of internal ...
You will participate in the development of regulatory strategies and help prepare regulatory submissions:US submissions include (k)s, IDEs, and Q-SubsHealth Canada amendmentsEU submissions include technical documentation filings and amendmentsOther markets as required (collaborate with International...
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...