- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- BioTalent (Carlsbad, CA)
- …medical device company in beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory ... and compliance initiatives. If you're passionate about navigating complex regulatory landscapes and enjoy collaborating cross-functionally, this is your opportunity… more
- Cleerly (Denver, CO)
- …and regulatory compliance issues. Mentorship & Development: Mentor and develop senior regulatory professionals, guiding them through complex regulatory ... in the job description. About the Opportunity As Principal Regulatory Affairs Specialist , you will provide ...track and control submissions, and review and advise on labeling to ensure compliance with regulatory filings.… more
- EPM Scientific (San Diego, CA)
- Title: Senior Specialist /Manager of Regulatory Affairs Summary: A global leader in medical technology is seeking an experienced and driven Regulatory ... while maintaining compliance Review and approve product labeling , promotional materials, and advertising content to ensure adherence to regulatory standards more
- CryoLife (Kennesaw, GA)
- …information about Artivion, visit our website, www.artivion.com. Position Overview: The Regulatory Affairs (RA) Specialist is responsible for supporting ... for performing regulatory activities in support of implementation. The RA Specialist will work independently and manage their own regulatory projects.… more
- DeepHealth (Boston, MA)
- …interactions with regulatory authorities Essential Duties and Responsibilities As the Senior Regulatory Specialist , this position will: Represent ... to swiftly adapt to challenges and opportunities alike. Role Summary The Sr. Regulatory Specialist is responsible for supporting DeepHealth's product and product… 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 ... regulatory authorities as required Review and approve product labeling to ensure compliance with regulatory requirements...approve product labeling to ensure compliance with regulatory requirements What will you need to be successful?… more
- Stryker (Weston, FL)
- We are seeking a ** Senior Regulatory Specialist ** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid ... or Weston, FL. **What you will do** As the ** Senior Regulatory Affairs Specialist ** ,... strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs Specialist ... You will provide expertise in sustaining work, supporting product changes, labeling updates, and regulatory process enhancements for both established… more
- Danaher Corporation (New York, NY)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I ... for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I...Health Canada filings, and Technical File authoring. + Provide regulatory guidance on product labeling , marketing materials,… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team... guidance throughout the product lifecycle, including development, planning, labeling , and claims, while maintaining current product registrations +… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine… more
- Medtronic (North Haven, CT)
- …submissions, license renewal and annual registrations. + Recommends changes for labeling , manufacturing, marketing, and clinical protocol for regulatory ... **A Day in the Life** 1) Review promotional material. 2) Perform regulatory evaluation of the change development project/engineering change orders. 3) Responsible… more
- Edwards Lifesciences (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a crucial role in supporting Medication ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- J&J Family of Companies (Santa Clara, CA)
- …sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist assisting with Advertising and ... assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines... stakeholders to help ensure that changes in product labeling are appropriately reflected in promotions and advertising. +… more
- Medtronic (Minneapolis, MN)
- …innovation in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST ** In collaboration with leading clinicians, ... and web-based applications that directly affect and improve patient's lives. The Senior Regulatory Affairs Specialist develops strategies for worldwide… 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 medical device regulatory strategies to obtain timely approvals from… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulations (eg, FDA Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive ... customer satisfaction + Support the monitoring and interpreting of current and new regulatory requirements and international standards for US and RoW + Support that… more
