A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
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 Associate Regulatory Operations Specialist (Remote). ...
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...
A company is looking for an R&D Regulatory Specialist to develop and implement regulatory strategies for products in the biotechnology and pharmaceutical industry. ...
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...
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. ...
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 ...
Drafts, edits and compiles technical documentation and design dossier in support of CE mark regulatory filings. Prepare regulatory submissions for FDA A2F. Research FDA, CMDR, MDR, IVDR and UK MDR2002 guidance documents for regulatory requirements. Review labeling, package inserts, ad materials and ...
Seeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory department. Work closely with hospital administration, clinical departments, and external regulatory agencies to develop, implement, and monitor compliance initiatives, policies, and proced...
Senior Cybersecurity Regulatory Specialist $175k at MedCrypt (United States). Senior Cybersecurity Regulatory Specialist $175k. As a Cybersecurity Regulatory Specialist, you will be working as a member of MedCrypt’s Services team. The Cybersecurity Regulatory Specialist will work closely with the Se...
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...
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 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...
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...
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...
Seeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory dept. Work closely with hospital administration, clinical departments and external regulatory agencies to develop, implement and monitor compliance initiatives, policies, and procedures. Co...
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...
Title: Regulatory Affairs Specialist - Hybrid. For further inquiries regarding the following opportunity, please contact our Talent Specialists:. ...
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 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 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...