Staff Regulatory Affairs Specialist

🕒 June 28

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

PROCEPT BioRobotics

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2009

🏥 Healthcare

🔧 Hardware

🤖 Artificial Intelligence

💰 $175M Post-IPO Secondary - PROCEPT BioRobotics on 2024-10

Healthcare • Hardware • Artificial Intelligence

PROCEPT BioRobotics is a medical technology company that develops AI-powered robotic systems for the surgical treatment of benign prostatic hyperplasia (BPH). Their flagship offering, Aquablation therapy delivered via the HYDROS and AquaBeam robotic systems, is an ultrasound-guided, robotic-assisted waterjet procedure designed to precisely remove prostate tissue while preserving sexual function and continence across prostates of varying shapes and sizes. The company emphasizes computer-assisted treatment planning, clinical evidence of safety and durability, and robotic hardware and software (including AI features) to support urologic surgery.

📋 Description

• Act as a lead regulatory representative on core product development teams • Communicates regulatory requirements and impact of regulations to project teams • Provides input related to FDA and international product registrations and licensing requirements • Develop global regulatory strategies for new and modified products • Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW) • Lead regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR) • Independently identify and problem solve regulatory and compliance issues, and escalate to senior management as necessary • Provide effective communication, and quick responses to internal customers • Drive continuous improvement in internal processes and customer satisfaction • Identify, develop, and mentor high performing regulatory talent • Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective • Execute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required content • Draft and execute comprehensive regulatory impact assessments for design control changes to existing products • Performs other duties and assignments as required.

🎯 Requirements

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications) • 8 years experience with a B.S. or 6 years experience with a M.S. in regulatory submissions for medical devices • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC) • Ability to work effectively on project teams • Must be able to manage multiple and competing priorities and manage programs with minimal oversight

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities