- 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)
- …will need to demonstrate knowledge of DP technical process, manufacturing operations , scientific method, basic regulatory compliance expectations, and ... work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive… 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 ... locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: CRM Cardiac Rhythm Management LOCATION: United States >… 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
- Ascend Performance Materials (Decatur, AL)
- …(member of the site leadership team) Direct Reports: Production Managers and Operations Specialist REQUIRED EXPERIENCE Bachelor of Science in Chemical ... of a collaborative environment where your work drives meaningful global impact. The Operations Director partners with the site leadership team to drive all aspects… more
- Aditi Consulting (Newbury Park, CA)
- …will need to demonstrate knowledge of DP technical process, manufacturing operations , scientific method, basic regulatory compliance expectations, and ... in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach. Proactively… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The regulatory operations specialist position provides support across multiple functional ... systems, and contribute to the accuracy and efficiency of regulatory operations . + Act as the liaison...Regulatory Management in the preparation and coordination of regulatory submissions . Ensures submission components are accurate,… more
- System One (Florham Park, NJ)
- Job Title: Manager, Regulatory Operations Documentation Specialist - Contractor Location: Florham Park, New Jersey - hybrid 50% Type: Contract Compensation: ... - $85 hourly Overview This role will lead the Regulatory Operations - Documentation Specialist ...formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. It also includes the archiving… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …advanced degree prefferred. + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global ... **Job Description Summary** Staff Regulatory Affairs Specialist - Franklin Lakes...is responsible for preparation of US and CE marking submissions /registration activities, completing comprehensive regulatory assessments for… more
- Kelly Services (Valencia, CA)
- …in Valencia, CA, with occasional work in Burbank. If you have expertise in regulatory submissions and quality operations in the medical device sector, ... Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position...the DQO in maintaining Quality Operations and Regulatory Program. + Handle regulatory submissions… more
- Philips (Plymouth, MN)
- …submissions , Pre- Submissions , EU MDR Technical Documentation, and global regulatory submissions , ensuring robust compliance and strategic alignment. Drive ... Join RespirTech's team in Plymouth, MN as a Principal Regulatory Affairs Specialist , where you will develop...Pre- Submissions , EU MDR Technical Documentation, and global regulatory submissions /registrations. + You have expertise in… more
- UPMC (Pittsburgh, PA)
- …of cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time ** Regulatory Specialist ** to help support the Oncology Clinical Research Services ... trial activation process while working Monday through Friday daylight hours. The Regulatory Specialist 's purpose is to develop regulatory forms/documents… more
- J&J Family of Companies (Santa Clara, CA)
- …In collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and EU. ... Description:** Johnson & Johnson is hiring for a **Sr Regulatory Affairs Specialist ** **- Shockwave** to join...Support international regulatory team with submissions to other geographies… more
- J&J Family of Companies (Santa Clara, CA)
- …In collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and EU. ... Description:** Johnson & Johnson is hiring for a **Sr.** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical**...Support international regulatory team with submissions to other geographies… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions , interact with ... Become a **maker of possible** with us. The Sr. Regulatory Affairs Specialist independently supports projects to...labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions , EU… more
- Medtronic (Lafayette, CO)
- …requirements + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and ... compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible...standards + Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements… more
- Abbott (Santa Clara, CA)
- …clinical documentation for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact of changing ... catheters and software, vessel closure devices and peripheral stents. This **Senior Regulatory Affairs Specialist ** position is an onsite opportunity working out… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a 6-month contract opportunity with a leading molecular diagnostics company ... progress in the biotechnology realm. **Workplace:** Remote US **Position Title:** Regulatory Affairs Process Specialist **Position Type:** 6-month contract **Pay… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with ... FDA's guidance on device versus non-device functionality. + Prepare, submit, and manage regulatory submissions for SaMD products. + Evaluate the impact of… more
