A company is looking for a Senior Regulatory Specialist to support product compliance strategies and ensure regulatory standards are met. ...
Title: Regulatory Affairs Specialist - Hybrid. For further inquiries regarding the following opportunity, please contact our Talent Specialists:. ...
A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities including all programs related to FDA and QSR compliance. Works with Regul...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
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...
Responsible for regulatory compliance activities associated with commercialized products. Assess manufacturing changes for reporting changes to global regulatory agencies. Prepare, compile and publish electronic post-market regulatory submissions. Review of product labeling, literature and Web site ...
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...
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...
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 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 ...
We are hiring a Senior Regulatory Specialist for an established in-vitro diagnostics company in San Diego, CA. This is hybrid on-site role 3 days per week and requires at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship. Drafts, edits and compiles technical documentatio...
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips’ Ultrasound business. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan...
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 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...
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...
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 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...
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...
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...
Title: Regulatory Affairs Specialist - Hybrid. For further inquiries regarding the following opportunity, please contact our Talent Specialists:. ...
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...
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:. ...
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...
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...