- dsm-firmenich (Exton, PA)
- …growth and development. + Manage the preparation of applicable technical sections of regulatory documents ( FDA 510k, IDE, PMA, CE), grants, & patent filings. ... **Manufacturing Engineering Manager ** **Exton, PA** **(On-Site)** The Manufacturing Engineering ...development, scale up, and commercialization of new and existing product lines and tooling for Polymer, Device and Natural… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** The Director of Product Marketing, Enterprise Imaging manages our go to...communications and sales leadership. + Work collaboratively with training manager to ensure all level of sales are prepared… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Vial Filling Process Owner Manager **Location** : Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, ... and their families. This is a 3rd shift position. Manages process within a product team to meet goals and priorities. Assures operations are conducted in compliance… more
- Philips (New Kensington, PA)
- …and issue resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage ... or Biomedical + A Minimum of 8+ years of professional experience in product /solution development within FDA -regulated medical device or technology sectors. +… more
- Merck (Harrisburg, PA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this ... programs and protocol for use of pharmaceuticals, animal monitoring products, product use directions, adverse event reporting, dealing with Ruminant growth and… more
- Penn Medicine (Berwyn, PA)
- …all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, ... each day. Are you living your life's work? Job Title: Associate Practice Manager Department: Cancer Ctr VF Location: Penn Medicine Valley Forge- 1001 Chesterbrook… more
- Brenntag AG (Reading, PA)
- …systems including policies, procedures, and quality manuals. + Hands-on expertise with regulatory frameworks and standards such as FDA , EMA, ICH guidelines, ... Your Role The Americas Regional Facilities Quality Manager serves a critical role in ensuring the...programs to ensure that all operations meet the strict regulatory , industry, and corporate standards unique to these highly… more
- PCI Pharma Services (Philadelphia, PA)
- …network to pioneer and shape the future of PCI. The Sr. Operations Manager is responsible for the safety, quality, and operational excellence for Advanced Drug ... procedures, along with all federal, state and local regulations, including OSHA, FDA , cGMP standards and employment law + Demonstrate substantial knowledge of the… more
- J&J Family of Companies (Horsham, PA)
- …America **Job Description:** We are searching for the best talent for a **Senior Manager , Health Care Compliance Officer** to be based in Horsham, PA. Our expertise ... the way. Learn more at https://www.jnj.com/innovative-medicine. **Purpose:** The Senior Manager , Health Care Compliance Officer will be responsible for collaborating… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …nurses, patients as well as external regulatory bodies, such as US FDA and notified body, concerning products issues, product information, patient requests ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more