- Medtronic (Santa Rosa, CA)
- …members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff . Strategic direction is ... activities/needs as they arise. **Role and Responsibilities** + Works with OU Regulatory Affairs management and staff to build and/ or increase knowledge… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - International ... requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** Staff Regulatory Affairs Specialist - Franklin Lakes NJ BD Specimen Management (SM) offers a comprehensive range of solutions ... management products, to sample analysis and accurate reporting. The Staff Regulatory Affairs Specialist is...to partners. + Assist and manage Notification of Change (NOC)/ International Regulatory Affairs assessments of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role in ... Support the monitoring and interpretation of current and new regulatory requirements and international standards for the...QMS requirements are followed and executed consistently from a Regulatory Affairs perspective. + Support efforts for… more
- Stryker (Mahwah, NJ)
- …products are developed and launched with precision. **What you will do:** As the Staff Regulatory Affairs Specialist, you will work with minimal supervision ... and more satisfying lives. We are currently seeking a Staff Regulatory Specialist to join our Mako...throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part… 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 ... a related field. + 3-5 years of practical experience regulatory affairs , with a focus on SaMD....Software Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO… more
- Stryker (San Jose, CA)
- …the goal of facilitating staffing, resolving resource allocation conflicts, and monitor staff utilization on the activities that will generate the highest business ... prioritization process. May recruit, hire, onboard, manage, and develop direct staff .* Build and sustain effective stakeholder relationships at all levels,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs /Compliance experience in medical devices + Experience with end-to-end SaMD ... (including all documents required under risk files). + Knowledge of global Regulatory Affairs requirements, regulations, and standards + Strong prioritizing,… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global ... their assigned projects. This role is responsible for linking regulatory affairs information to internal and external...+ Facilitate partnerships, both formal and informal, with key regulatory agency review staff . + Participate in… more
- Abbott (Lake Forest, IL)
- …Our location in **Lake Forest, IL** currently has an opportunity for the **Director of Regulatory Affairs .** The function of a Director of Regulatory ... metrics/information. The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide. **WHAT YOU'LL… more
- Stryker (Shirley, MA)
- …meet regulatory requirements + Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff + Ensure that departmental Standard Operating ... We are currently seeking a **Manager, Regulatory Affairs ** to join our Joint...experience + Demonstrated experience in interacting with FDA review staff and inspectors, Notified Bodies and international … more
- Ascendis Pharma (Palo Alto, CA)
- …days per year domestically and internationally + Broad experience in Regulatory Affairs , working directly with FDA and international agencies with focus on ... we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work on-site at ... people monitor their glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC** position will work closely with in-country… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technical files for registration of Olympus products in the EU. + Interface with International Regulatory Affairs Team to support preparation of dossiers for ... Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team in ... Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working out ... regulatory requirements to development and manufacturing teams + Prepare robust regulatory applications (FDA and international regulatory agencies) to… more
- Stryker (Weston, FL)
- …meet regulatory requirements + Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff + Ensure that departmental Standard Operating ... We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint...and cross-functional partners, as well as with individuals across international locations and time zones, cultures, and languages to… more
- Abbott (St. Paul, MN)
- …and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager** position is an onsite opportunity ... Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine...regulatory activities. + Provide mentorship to other RA staff in department. + Accountable for communication to cross-functional… more
- Teva Pharmaceuticals (West Chester, PA)
- Director, Regulatory Affairs - Dossier Project Manager Date: Jul 19, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... Medicine Dossier Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...Regulatory Authorities. * Provides training and mentorship to regulatory staff . **Your experience and qualifications** *… more
- Medtronic (Minneapolis, MN)
- …Life** + Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new ... connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading...as needed. + Provide business and product information to international regulatory staff to enable… more