- Merck & Co. (South San Francisco, CA)
- …to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions .The candidate will play a key role in developing, ... ability to influence scientists to adapt to positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with… more
- Aequor (Thousand Oaks, CA)
- …work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive ... for the introduction of new products into the manufacturing plant. This " Specialist Manufacturing" role will serve as a New Product Introduction Lead within… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM ... for submissions . Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews… more
- Envista (Brea, CA)
- Job Description: The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory ... Responsible for global submissions (as required). Tracks submissions and maintains electronic and paper regulatory ...Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA, HC, EU and… more
- Intuitive (Sunnyvale, CA)
- …communication skills, proven ability to translate technical documentation into effective regulatory submissions . Good interpersonal skills and able to work ... experience is required. Minimum 4 years of working experience supporting international submissions preferred; Previous China regulatory affairs experience is a… more
- Boston Scientific (Irvine, CA)
- …Urology solutions. We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active ... implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing...be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product… more
- Globus Medical (Audubon, PA)
- …in medical device development and registration of products Demonstrated knowledge of US regulatory submissions ; Pre-Sub, and 510(k); working knowledge of IDE and ... their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting...PMA submissions a plus Experience assessing regulatory impact… more
- EPM Scientific (Philadelphia, PA)
- …in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. This position ... regulatory strategy and supporting innovative product development. The Regulatory Affairs Specialist should have the following qualifications: Bachelor's… more
- Cleerly (Denver, CO)
- …States and account for geography when determining base salary. Responsibilities (General) Regulatory Submissions & Liaison: Prepare, review, and complete ... in the job description. About the Opportunity As Principal Regulatory Affairs Specialist , you will provide ...regulatory submissions to global regulatory agencies (eg, FDA,… more
- Abbott (Sylmar, CA)
- …Use (IFU) by editing for grammar, consistency, style, and format. Assists with Regulatory submissions and filings by providing the relevant labeling samples and ... diversity, working mothers, female executives, and scientists. The Opportunity The Labeling Specialist II position works out of our Sylmar, CAlocation in the Cardiac… more
- Roots Through Recovery (Long Beach, CA)
- …in their roles. We are actively seeking an Admissions and Intake Specialist within our substance use and co-occurring disorder treatment intensive outpatient program ... essential member of our team, the Admissions and Intake Specialist plays a vital role in helping individuals navigate...they contact us via phone, website chat or form submissions . Their primary responsibility is to guide prospective clients… more
- CorDx (San Diego, CA)
- …within the medical device or In Vitro Diagnostics industry. Experience with regulatory submissions , including 510(k) and CE marking, is highly preferred. ... critical questions in healthcare. Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000 - $95,000… more
- Katalyst HealthCares and Life Sciences (Pleasanton, CA)
- …assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change ... development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions , regulatory commitments,… more
- Calyxo (Pleasanton, CA)
- …post-market regulatory activities, including medical device reporting (MDR), regulatory submissions , and promotional material reviews. This role involves ... diverse atmosphere. Summary: As a key member of the Regulatory Affairs team, you will play a vital role...as Medical Affairs, Quality, and Risk Management to maintain regulatory compliance, support product changes, and respond to … more
- StateJobsNY (New York, NY)
- …of Financial Services is seeking candidates for the position of Financial Services Specialist 2 (Compliance) in Life Bureau. Duties include, but are not limited to, ... institution programs, policies and procedures for compliance with legal and regulatory requirements. *Evaluating financial costs for the failure of financial… more
- Boston Public Health Commission (Boston, MA)
- …sections of proposals. Aid in preparing administrative components of proposal submissions . Ensure budgets align with BPHC guidelines and policies. Provide ongoing ... with the Post-Award grants team to provide guidance to PIs on regulatory and compliance monitoring post-award. Promote health equity, inclusion, and diversity.… more
- Cincinnati Children's (Burnet, TX)
- …of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use ... all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines. Under the guidance of… more
- columbiabank (San Diego, CA)
- …workflow and functions or related banking or financial fields. Basic understanding of regulatory requirements or ability to understand and comply with regulatory ... be responsible for any fees related to unsolicited resume submissions . Staffing and recruiting agencies are not authorized to...or to any Umpqua Bank employee and any such submissions will be considered unsolicited unless requested directly by… more
- Aditi Consulting (Newbury Park, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. ... in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach. Proactively… more
- Ascend Performance Materials (Decatur, AL)
- …production assets. Compliance & Risk Management Ensure adherence to regulatory and corporate requirements, including ESSH core practices, environmental compliance, ... of the site leadership team) Direct Reports: Production Managers and Operations Specialist REQUIRED EXPERIENCE Bachelor of Science in Chemical Engineering or Fibers… more
