- J&J Family of Companies (Santa Clara, CA)
- …of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Regulatory Affairs Manager works closely and partners with internal ... meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge of scientific, regulatory… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs ,… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …**Position Summary:** The Technical Quality Manager will support Corp Quality and Regulatory Affairs . Responsible for ensuring compliance with ... support to marketing and sales in China * Manages quality or regulatory affairs projects...on issues. The estimated pay scale for the Technical Quality Manager role based in Los Angeles,… more
- ThermoFisher Scientific (Grand Island, NY)
- …to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager , Regulatory Affairs - Drug Support Strategy is a new ... as well as customer and employee needs. The Sr. Manager will develop and pursue world-class regulatory ... quality + Understanding of business processes - Regulatory Affairs systems **Physical Requirements / Work… more
- Unilever (El Segundo, CA)
- …has excellent communication skills and loves to collaborate with cross-functional partners. The Regulatory Affairs Manager will lead daily end-to-end ... SmartyPants brand. This role will partner with Product Development, Quality , Sales, and Marketing teams to provide regulatory...LOCATION: El Segundo, CA HOURS: Full time, exempt (salaried) MANAGER : Sr. Director, Regulatory Affairs … more
- United Therapeutics (Research Triangle Park, NC)
- …the back of your hand - you might be exactly who we're looking for. The Regulatory Affairs Manager will manage and lead the preparation, compilation, and ... tasks as required + Manage and lead updates to quality sections of regulatory filings (includes INDs,...discipline + 8+ years of direct experience with a regulatory affairs CMC role with a bachelor's… more
- Abbott (Alameda, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs ,… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Licensing Manager , Regulatory Affairs , will lead a licensing team and manage the completion of various regulatory work ... projects. **Job Description** **Essential Responsibilities:** As the US Licensing Manager , Regulatory Affairs , you will:...direct reports to support project delivery on time with quality + Manage US Licensing Technical Leaders assigned to… more
- Dentsply Sirona (Milford, DE)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +… more
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... departments to ensure product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate. + Review and… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager ** position is an onsite opportunity ... years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related… more
- Astellas Pharma (Northbrook, IL)
- …& People Management** + Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, ... discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred. + Strong scientific knowledge and … more
- Stryker (Redmond, WA)
- Stryker is seeking an **Associate Manager , Regulatory Affairs ,** to support **Emergency Care!** You will provide leadership, direction, and coordination for ... biotechnology, or other highly controlled environments. + 3+ years of Quality or Regulatory Affairs experience. + Previous experience in a technical… more
- CAE USA INC (TX)
- About This Role Regulatory Affairs Manager (CAE SimuFlite, Inc.; Las Vegas, NV): Direct the preparation and submission of regulatory agency applications, ... EASA, and others), internal stakeholders, and external stakeholders regarding regulatory quality assurance and safety matters. Oversee...email their resume to ###@cae.com & type job title " Regulatory Affairs Manager " & job… more
- Haleon (Warren, NJ)
- …It's an opportunity to be part of something special. **About the role** This **Senior Manager , Regulatory Affairs - OTC** has responsibility for end-to-end ... Participates in the review of promotional materials + Ensures quality and process improvements within US and provides cross...similar discipline + Minimum 8 years of experience in regulatory affairs + Experience working on FDA… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA...indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality , Management and other areas of… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... affairs related to the development of novel therapeutics including quality , preclinical and clinical areas of drug development and the policies/procedures… more
- Beth Israel Lahey Health (Boston, MA)
- …you're not just taking a job, you're making a difference in people's lives.** The Manager of Business and Regulatory Affairs oversees financial performance, ... agencies (CMS, UNOS/OPTN, SRTR) as well as annual updates. 11. Manages regulatory /QAPI process including workgroups to supports transplant quality projects with… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …best self. Become a **maker of possible** with us. **Job Summary:** The Senior Regulatory Project Manager is responsible for regulatory strategy development ... of Companion Diagnostics (CDx) and IVD products. The Senior Regulatory Project Manager will provide oversight and...Affairs , R&D, QA, and Business Development to align regulatory plans with, and provide inputs and updates to,… more
- Kelly Services (Anaheim, CA)
- **Director of Quality and Regulatory Affairs ** Kelly(R) Science & Clinical is seeking a **Director of Quality and Regulatory Affairs ** for a ... In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development,… more
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