Regulatory Affairs Specialist
Philips, Newtown, Cambridge
Regulatory Affairs Specialist
Salary not available. View on company website.
Philips, Newtown, Cambridge
- Full time
- Permanent
- Remote working
Posted today, 17 Oct | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: 306034cf56a449319be91875461919b8
Full Job Description
- Assists with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.
- Advises product design teams on regulatory strategy and requirements for specific new products/solution.
- Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations. Support both internal and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body.
Minimum of a Bachelor of Science degree in a technical, Quality, Regulatory or business discipline. MS desired. - Minimum of 1+ years' experience in FDA regulated Medical Device/Healthtech environments.
- First line experience with US FDA, China NMPA and EU MDR is required. Knowledge of ISO 13485 and QSR requirements.
- Experience with submission of Technical Documentation, 510K, and registrations of medical devices globally is preferred. Experience with Software as Medical Devices (SaMD) is preferred.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
The pay range for this position In WA and MA is $56,000 to $95,000, Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.philipsusbenefits.com/) . At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.