- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure… more
- BioTalent (Carlsbad, CA)
- …in beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory submissions and compliance ... Qualifications: Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry. Hands-on experience with 510(k), IDE,… more
- Conmed (Denver, CO)
- Job Summary: The Sr. Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the ... scientific or technical disciple. Experience : 5+ years of Regulatory Affairs experience (Medical device industry preferred). Regulatory working knowledge of product… more
- Boston Scientific (Maple Grove, MN)
- …and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the Interventional ... Cardiology Regulatory Affairs team and will be supporting regulatory submission activities...a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.… more
- JCW Group (Austin, TX)
- …Job type: Permanent/Fixed Term Catalyst Life Sciences is on the search for a Senior Regulatory Affairs Specialist to join a team on site in Austin TX. If you ... would like to be a part of aa cutting edge, Medical Device company solving cardiac and vascular challenges, then please apply! Qualifications/Responsibilities: 4-5 years of direct experience with Class III Implantables Prior knowledge of submitting and filing… more
- Marmon Holdings, Inc. (Addison, TX)
- …accordance with applicable regulatory requirements (FDA, ISO, CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and ... Strategy RA, Post-Market RA, etc.). With increasing levels, the Regulatory Affairs Specialist will be expected to provide increasing leadership and mentoring… more
- Experis (St. Paul, MN)
- …client, a global leader in medical device manufacturing , is seeking a Regulatory Affairs Specialist to join their team, fully remote , reporting to Maplewood, ... MN. As a Regulatory Affairs Specialist , you will be part of the regulatory affairs team supporting global healthcare initiatives. The ideal candidate will… more
- Scientific Protein Laboratories (Waunakee, WI)
- …(APIs). SPL has an exciting opportunity to join the team as a Regulatory Affairs Specialist . This position is responsible for supporting day to day Regulatory ... Affairs (RA) activities at SPL, Mobren as well as supporting external customer requests. Responsibilities include maintaining and responding to established timelines… more
- California State University (San Diego, CA)
- Science and Research Writer and Media Relations Officer (Public Affairs /Communications Specialist III) Job no: 550213 Work type: Staff Location: San Diego ... Relations Officer to join the Strategic Communications and Public Affairs (StratComm) team. In this role, you will help...As a member of the Strategic Communications and Public Affairs team, you will collaborate with faculty, university leaders,… more
- Smith & Nephew (Pittsburgh, PA)
- Principal Regulatory Specialist , Robotics (Pittsburgh, PA) Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living! In ... US and EU markets. You act as the Regulatory Affairs (RA) lead and subject matter expert (SME) on...Master's degree a plus 8+ years experience in Regulatory Affairs Experience with a Class II devices Knowledge and… more
- Arkema (Broomall, PA)
- …to assure compliance with legal and corporate product stewardship and regulatory affairs requirements in a cost effective and efficient manner. This position reports ... Hazardous Materials Transportation and HTSUS product classifications), product regulatory affairs , and product risk management as such areas may impact… more
- Boston Scientific (Maple Grove, MN)
- …qualifications: Minimum of a Bachelor's Degree 7+ years of experience in Regulatory Affairs , or 5+ years of experience with an advanced degree (Master's or PhD) ... in a relevant scientific or engineering discipline Demonstrated leadership, strategic thinking, project planning, and project management skills Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to… more
- Boston Scientific (Marlborough, MA)
- …of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development ... to discuss your preferred working location with your Talent Acquisition Specialist . Your responsibilities will include: Coordinate, compile, and submit US and… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- …Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, ... performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies. Serve as the global regulatory liaison and primary… more
- Cynet Systems (Irvine, CA)
- …Pay Range: $44.60hr - 49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission ... by China and Hongkong affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions. Participate in providing guidance on strategies and contingency planning with respect to China and… more
- Intuitive (Sunnyvale, CA)
- …[Sr. Regulatory Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist ] Experience: Minimum 5 years relevant experience working in a medical device ... company (can be in combination with a regulatory degree; eg, Masters in Regulatory Science) and/or applicable work for a regulatory agency 4 years of experience in submissions and technical documentation for medical devices (can be in combination with a… more
- Merck & Co. (Boston, MA)
- …accelerating research and innovation.- We are seeking a passionate and knowledgeable Senior Specialist to join our Library team.- In this position, you will be ... linking our stakeholders with scientific and medical information resources. A successful Senior Specialist will have a drive for mastering a wide range of databases… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Sr. Medical Information Specialist is responsible for meeting the medical information needs of internal and external ... member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to:Leveraging scientific expertise… more
- FirstEnergy Corp. (Akron, OH)
- …line routing and siting process. Support efforts to work with external affairs teams and educate the public (landowners, thought leaders, elected officials) about ... Engineering, Real Estate, PJM Strategy, Legal, Corporate Communications, and External Affairs to foster two-way communications between key stakeholders and the… more
- Globus Medical (Audubon, PA)
- …can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for ... study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting...a plus Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within… more
