Amick Brown is seeking an experienced Sr. Regulatory Affairs Specialist for our direct client. Location:Remote Duration: 12 Months Estimated pay range: $46.76 - $58.46 an hour per client contract and candidate skills, experience and work location.
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier.
Roles and Responsibilities Main activities
Provides regulatory guidance and defines regulatory strategy for digital products by translating complex regulatory concepts into understandable principles
Directs or performs coordination and preparation of document packages for complex medical device regulatory submissions based on company objectives and timelines
Leads or compiles all materials required in submissions, license renewal and annual registrations
Represents our clients regulatory strategy with US FDA or other competent authorities
Supports regulatory strategy, labeling, manufacturing, marketing, and clinical protocol to achieve regulatory clearance.
Independently advises cross-functional teams and share knowledge and expertise to support development and training of team members
Supports clearance of non-medical devices
Ensures that company procedures, processes and documentation meet requirements of the Quality Management System, ISO 13485 and other applicable regulations
Implements and supports Quality Management system activities such as CAPA, management review and internal & external audits as needed
Other regulatory tasks and projects may be assigned as necessary
Required Knowledge, Skills, and Experience
At least 8+ years of significant experience in regulatory affairs and quality compliance for medical devices according to EU regulation
A Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
In Depth knowledge of US FDA 21 CFR 820.30 and US clearance pathway (510(k)), including US FDA guidances on digital devices
Knowledge of European Medical Device Regulation (2017/745/EU)
Significant experience in design control, including new product development
Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results.
Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
Orientation for work result details, with emphasis on accuracy and completeness
Fluent (C1 minimum) in written and spoken English
General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
Preferred Knowledge, Skills, and Experience
Prior experience working on Software as a medical device and/or digital technologies
Knowledge of non-medical device regulations (eg FCC, CE Marking)
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits: