- Stryker (Denver, CO)
- …Bachelor's degree * 10+ years of work experience required * 7+ years medical device or marketing/sales experience preferred * Experience developing strategic ... working with Surgeons, KOL or Clinical influencers **Preferred** + 5+ year in sales or medical education in the medical device industry + People leadership… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more
- Wolters Kluwer (Chicago, IL)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Cook Medical (West Lafayette, IN)
- …or 2 years of experience as Monitoring Manager; * Sound knowledge of GCP and global medical device regulations, with experience working on medical device ... correctly understood and applied; + Through close collaboration with Clinical Affairs global leadership, help ensure global alignment regarding monitoring processes… more
- Astrix Technology (Boston, MA)
- …Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that inform strategic ... medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of therapeutic… more
- Actalent (Irvine, CA)
- …to lead Quality Assurance (QA) activities for a strategic M&A initiative in the medical device industry. This role demands a strong leader capable of navigating ... complex situations and collaborating effectively with cross-functional teams, including Regulatory Affairs (RA) and Clinical Affairs (CA). Responsibilities +… more
- Philips (San Diego, CA)
- … Medical /Clinical Affairs or Medical Safety/ Medical Affairs Risk Management in Meical Device industry. Prior hands-on bedside/clinical experience ... ** Medical Safety Manager, Complaints Handling** The Medical...assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical… more
- AbbVie (Waco, TX)
- …departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs , Clinical Studies, Customer Care, Operations, and Marketing departments ... 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations. + Conduct,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business ... Duties** + Supports supplier quality activities for sourced finished Medical Device products and leads these supplier...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Medical Director Pharmacovigilance, Rare Disease & PDT **POSITION DESCRIPTION** :… more