- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs , Tactical Implementation, on the Regulatory ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Eisai, Inc (Nutley, NJ)
- …Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs , R&D, etc.) in executing both high-priority strategic initiatives (eg, ... and collaborate with global privacy counterparts to ensure compliance with international frameworks (eg, GDPR, PIPEDA) and alignment on enterprise-wide privacy… more
- Insmed Incorporated (NJ)
- …Governance, Supply, Global Brand Strategy Team, etc)Work closely with Legal, Regulatory , Compliance, Medical Affairs , Market Access, Advocacy, and Commercial ... and go-to-market frameworks tailored to dermatologists treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical and research… 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 ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and connected technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning ... medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class ...Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... also have access to: + Career development with an international company where you can grow the career you...their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**… more
- Stryker (Mahwah, NJ)
- **Senior Manager , Regulatory Affairs - Joint Replacement Division** **Location:** Hybrid - Mahwah, NJ As the **Senior Manager , Regulatory Affairs ... new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to... regulatory submissions to authorities. + Domestic and international regulatory guidelines, policies and regulations +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a… 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, ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +... projects. + In-depth knowledge of FDA 510(k) and international regulations (eg, EN ISO 13485, EU MDR). +… more
- Liberty Utilities (Merrick, NY)
- Senior Manager , Rates and Regulatory Affairs Saint Lawrence Gas Merrick, NY, US, 11566 **Algonquin Power & Utilities Corp. (AQN), parent company of Liberty, ... is a diversified international generation, transmission, and distribution utility. AQN is committed...our customers, communities, employees, and shareholders.** **Purpose** The Senior Manager Rates and Regulatory Affairs … more
- Abbott (Lake Forest, IL)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** The **Sr. Regulatory Affairs Manager ** hired in this role will work ... also have access to: + Career development with an international company where you can grow the career you...for millions of people. **What you will do** Provide regulatory affairs project management for various areas,… 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
- Roche (Indianapolis, IN)
- …be working closely with colleagues in other departments and other counties. As a Regulatory Affairs Manager focused on Companion Diagnostics (CDx), with ... love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the...have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Abbott (Alameda, CA)
- …years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... also have access to: + Career development with an international company where you can grow the career you...with our new sensing technology. **The Opportunity** The **RA Manager ** will work on-site out of our Alameda, CA… 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 ... in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... with regulatory authorities. + Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory … more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager , Clinical Research Regulatory Affairs is tasked ... with oversight and governance of Regulatory Affairs department and involved in the day-to-day support of the clinical research studies conducted at Children's… more
- Abbott (Livermore, CA)
- …their lives. This position leads payor relations (including payor contracting) and regulatory affairs , which are foundational functions to driving ongoing ... live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify… more
