Regulatory Affairs Specialist
11720 North Creek Parkway N Bothell, Washington 98011 | Direct Hire
Position Title: Regulatory Affairs Specialist
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Bothell, Washington.
- Acts as primary interface between local and global regulatory teams
- Supports requests for client information and documentation in support of regulatory submissions
- Provides input to and supports maintenance of product technical files
- Evaluates product changes for regulatory impact, documents results, and generates Notified Body Notices of Changes as applicable
- Provides regulatory expertise to the Product Development and Operations teams, including labeling requirements and submission approval lead times
- Identifies and communicates new and revised regulatory requirements to the organization, and performs/coordinates impact assessment activities
- Maintains global client product regulatory approval status
- Facilitates Global Regulatory Assessments through engagement with our international regulatory professionals and international change committees.
- Primary contact/driver for client changes to OUS regulatory. Support site change implementation process to drive changes that affect ex-US markets.
- Serves as the focal point for change requests of the various regions, along with requests for information supporting global product registrations.
- Develops and maintains the underlying processes for this function including performance measures. Based upon system feedback, drives continual improvement in associated QPIs.
- Helps solidify and strengthen the Global Change Management support network and process through proactive engagement with international peers and key stakeholders.
- Provides training as required to both international and domestic groups in support of the overall process.
- This position requires a minimum of an undergraduate degree, preferable in a science related field.
- RAPs training preferred but not required.
- Requires 5-7 years of experience in the development, distribution and life-cycle management of medical device and pharmaceutical products.
- Possess a keen understanding of Change Management / Life Cycle Management of medical device and pharmaceutical products along with the impact of such changes on global product registrations.
- Demonstrated ability to work effectively in a self-directed, decentralized team environment of high accountability and complexity.
- Maintain and manage a complex portfolio of product and process changes. Develop, strengthen and continually improve supporting processes.
- Must possess knowledge of current drug and device regulations and regulatory agency organizations.
- Must possess good interpersonal abilities to work with peers and clients across the organization.
- Must possess excellent time management and organizational skills to maintain and manage a complex portfolio of changes and process demands.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.
I have an ability to connect with engineers easily, with an engineering background myself, I can relate and communicate using the same language. I have been working in Technical staffing at Protingent since 2011. I have two dogs, Kaleb & Kayce and two cats, Mika and Shiloh. I am originally from upstate New York, but love living in the Pacific Northwest! I have a passion for cars, old and new.