- 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
- University of Pennsylvania (Philadelphia, PA)
- …such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions . Communicate with study team members. ... submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… 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
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key...the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities… more
- Globus Medical, Inc. (Audubon, PA)
- …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 … more
- Hologic (Newark, DE)
- … Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and ... Regulatory Affairs Specialist 4 Newark, DE,...the international regulatory affairs group to support regulatory submissions worldwide for medical devices and… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! In ... your role as a Sr. Regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- Medtronic (Minneapolis, MN)
- …+ Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg, ... a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST ** In collaboration with leading clinicians, researchers and… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Stryker (Mahwah, NJ)
- …lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Specialist to join our Mako and Enabling Technology business within the ... with precision. **What you will do:** As the Staff Regulatory Affairs Specialist , you will work with...skills. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions ,… more
- Medtronic (Minneapolis, MN)
- …to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with ... + Experience working in regulated, biotechnology environment, including involvement with regulatory submissions , interactions with regulatory agencies (eg,… more
- Terumo Neuro (Aliso Viejo, CA)
- …the regulatory submission or complete submission. + Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the ... **12814BR** **Title:** Sr. Specialist , Regulatory Affairs **Job Description:** Responsible...of product changes on US, EU, Canada, and/or international regulatory strategy/ submissions per MicroVention procedures. + Review… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- Zimmer Biomet (Englewood, CO)
- …regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions , maintaining regulatory filings and licenses ... and resolution + Collaborate with international counterparts to support global regulatory submissions , approvals, and implementation rollouts + Perform timely… more
- Kelly Services (Valencia, CA)
- …Affairs Specialist - Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1 year) at a ... occasional work in Burbank. If you have expertise in regulatory submissions and quality operations in the... regulatory reviews, and participating in audits. The Regulatory Specialist will also act as a… more
- West Pharmaceutical Services (Exton, PA)
- …Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. ... Senior Specialist , Regulatory Affairs - Medical Device...+ Author and review US, EU, and additional international submissions with guidance for new products and product changes… 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...considering both domestic and international regulations + Prepare 510(k) submissions and technical documents to support CE mark and… more
