- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...orthopedic medical devices ; + Experience in medical … more
- Organon & Co. (Plymouth Meeting, PA)
- …GMP Quality Systems and regulatory requirements. + Experience in medical device Quality Systems is preferred, including familiarity with ISO13485, ... and foreign. + Provide oversight of contract manufacturing of drug delivery systems, medical devices and combination products. + Provide support to the contract… more
- West Pharmaceutical Services (Exton, PA)
- …5 years Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... With minimal support, the Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables and...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides … more
- United Therapeutics (Harrisburg, PA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Organon & Co. (Plymouth Meeting, PA)
- …or device operations (eg, manufacturing, process development, analytical, and quality assurance) is required. + At least five years of relevant experience, ... project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ... that make a meaningful difference in people's lives. Our medical devices , software and related services are...+ Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and +… more