View all jobs
Sr. Regulatory Affairs Specialist
Remote, RemoteAmick 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.
Job Description
Roles and Responsibilities
Main activities
Regular full-time employees are eligible for the following Amick Brown provided benefits:
Location: Remote
Duration: 12 Months
Estimated pay range: $46.76 - $58.46 an hour per client contract and candidate skills, experience and work location.
Job Description
- 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
- 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)
- RAC certification
- Prior experience working on Software as a medical device and/or digital technologies
- Knowledge of non-medical device regulations (eg FCC, CE Marking)
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- Health
- Vision
- Dental
- 401k with company match
- Paid time off.
- Sick Leave
- Long -Term Disability
- Life Insurance
- Wellness & Discount Programs