REGULATORY AFFAIRS SPECIALIST

Position Title: REGULATORY AFFAIRS SPECIALIST 3

Location: SUNNYVALE, CA

Role Type: Long term contract

Roles & Responsibilities:
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 Intuitive’s 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

Additional activities

• 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:

• 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, …)

Thank you

Job Type: Contract

Pay: $55.00 - $58.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• REGULATORY AFFAIRS: 8 years (Required)
• European Medical Device Regulation: 5 years (Required)
• US FDA 21 CFR 820: 5 years (Required)

Work Location: One location