- System One (Malvern, PA)
- …or equivalent, in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. ... Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device...and global regulatory requirements for class II medical devices including but not limited to… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Chemours (Harrisburg, PA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- 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 ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...orthopedic medical devices ; + Experience in medical … more
- Globus Medical, Inc. (Audubon, PA)
- …in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. + Excellent ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining… more
- Canon USA & Affiliates (Harrisburg, PA)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market - req1434**...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Belcan (Pittsburgh, PA)
- Medical Device Job Number: 358762 Category: Regulatory Description: Job Title: Assembler - Medical Device Location: Pittsburgh, PA. Zip Code: 15238 ... JOB RESPONSIBILITIES: This position will assemble and support the various medical device manufacturing processes. POSITION DUTIES & RESPONSIBILITIES: *… more
- Belcan (Pittsburgh, PA)
- Assembler - Medical Device Job Number: 358684 Category: Regulatory Description: Job Title: Assembler - Medical Device Location: Pittsburgh, PA Zip ... JOB RESPONSIBILITIES: This position will assemble and support the various medical device manufacturing processes. * Successfully completes all aspects… more
- Wolters Kluwer (Philadelphia, PA)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Jabil (West Chester, PA)
- …will support key quality systems, ensure compliance with internal and regulatory standards, and provide day-to-day engineering support to manufacturing operations. ... TIC, MIC, QIC). + Engage in internal/external audits and regulatory compliance activities. + Provide training and guidance to...Quality Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
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