A company is looking for a Senior Regulatory Compliance Specialist to assist with the implementation and maintenance of its Compliance Software Program. ...
Title: Regulatory Affairs Specialist - Hybrid. For further inquiries regarding the following opportunity, please contact our Talent Specialists:. ...
A company is looking for an Associate Regulatory Operations Specialist (Remote). ...
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...
A company is looking for a Food Regulatory Specialist to join their team remotely. Food Science, Biology, Chemistry, Toxicology, Nutrition preferred)Regulatory experience in the food industry6 months to 5 years of experience in Regulatory Affairs of a Consumer Products CompanyWorking knowledge of U....
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...
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...
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 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...
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...
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...
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 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...
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...
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...
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:. ...
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...
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 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...
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 ...
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 ...
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...