- J&J Family of Companies (Danvers, MA)
- …identifying critical path + Working knowledge of Microsoft Office Suite + Knowledge of FDA 21CFR820/821 and ISO 13485 requirements + Working knowledge of SAP a plus ... + Willingness to travel up to 20% both within US and International Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Parexel (Boston, MA)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before… more
- Cardinal Health (Peabody, MA)
- …and be responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA , State and local authorities. + Support and contribute to the development ... and implementation of innovative modifications to processes in order to improve the quality of service to our customers. + Will comply with vaccinations and background checks as required by the hospital customer. **Qualifications** + High school diploma, GED… more
- Medtronic (Danvers, MA)
- …documentation, including PFMEAs, control plans, and work instructions in compliance with FDA and ISO 13485 standards. + Partner with external suppliers and tooling ... vendors to ensure alignment on process capability, mold design, and material specifications. + Support cross-site AME initiatives across the East Region to standardize best practices and advance molding innovation strategies. + Serve as a technical mentor to… more
- Fresenius Medical Center (Lawrence, MA)
- …reduce training time of healthcare professionals; + Working on the FDA approval strategy, pre-submission process, and compilation of a pre-submission documentation; ... + Using computational (Excel, MATLAB, Python) and simulation tools (SolidWorks and PTC Creo) to analyze data and inform product decisions This is a hybrid position working 2 days/week at the office in Lawrence, MA and 3 days/week at a home office. **EOE,… more
- Fresenius Medical Center (Lawrence, MA)
- …product to supporting the released product. + Is familiar with and follows FDA /ISO Design Control principles and regulations in product development. + Designs and ... develops products that meet User inputs and supports business and marketing strategies to further generate revenue growth. + Applies Risk based procedures throughout the product development process and the product life cycle. + Authors testing plans,… more
- Edwards Lifesciences (Boston, MA)
- …R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical ... thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all… more
- Sumitomo Pharma (Boston, MA)
- …combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is ... preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan,… more
- J&J Family of Companies (Boston, MA)
- …in a fast-paced environment while managing multiple priorities. + Must not be debarred by FDA for work in any Medical Device business. + Must have a valid driver's ... license. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) + Employee may be required to lift objects up… more