Regulatory Manager

Please submit resumes to careers@palettelifesciences.com​ 

Position

Regulatory Manager

Reports to

Head of Regulatory

Location

Santa Barbara area, CA

Summary

The Regulatory Affairs (RA) manager is responsible for all regulatory activities for the US, EU, and other markets where Palette Life Sciences medical devices are sold.  The manager will implement overall regulatory strategies to ensure high quality submissions to FDA, Notified Bodies, TGA, and other regulatory bodies.

Responsibilities

  • Leads, coordinates, authors, and reviews regulatory filing documents

  • Prepares FDA submissions and CE Mark Technical Documentation, including PMA supplements and annual reports, 510(k) submissions, pre-submission meeting requests, design dossiers and technical files, and regulatory review of product changes to determine whether new submissions are required Communicates with FDA and Notified Bodies regarding regulatory requirements and strategies to legally place or maintain products in the market.

  • Coordinates, compiles, and prepares regulatory submissions/ documentation for OUS country notifications and registrations

  • Reviews promotional material to ensure compliance with approved/cleared indications for use

  • Assist with regulatory aspects of post market surveillance activities, including submission of post-approval study reports and communications with regulatory agencies about reportable adverse events

  • Collects documentation and coordinates with cross-functional teams to prepare regulatory submissions to regulatory agencies (or commercial partners)

  • Creates and maintains regulatory submission timelines and tracks deliverables to ensure company goals are met

  • Execute company’s regulatory strategy in the US and OUS

  • Conduct regulatory research and analysis

  • Keeps abreast of current regulatory landscape for medical device globally, e.g., FDA guidance documents, Medical Device Regulations (MDR), Medical Device Directive (MDD), EU guidance documents, etc.

  • Develops and communicates recommendations regarding new/emerging regulations to management and project teams

  • Identifies potential project issues proactively to allow implementation of appropriate regulatory strategies to mitigate risks

  • Interacts with regulatory authorities

  • Leads in the preparation of responses to questions from regulatory authorities

  • Facilitates the preparation of meetings with regulatory authorities (e.g., Q-Subs) to support regulatory filings

  • Provide in-house training in regulatory guidelines as applicable to team members

  • Assist with site audits by regulatory agencies

  • Evaluates, authors and reviews SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations

  • Performing other related duties as assigned

Job Requirements

  • BS Degree or higher with at least eight years of related work experience in Regulatory Affairs for medical devices

  • Prior working experience with FDA, Notified Bodies, TGA, other OUS regulatory bodies

  • Experience with Class III/ high risk classification devices

  • RAC certification will be a plus

  • Demonstrate understanding of laws, regulations, standards, and guidance and processes that govern content, maintenance, and submission of documents required by regulatory authorities for all classes of devices, especially Class III (US and EU).

  • Proven ability to successfully interact with regulatory authorities and manage major submissions and critical projects to meet deadlines. Proven track record and experience with regulatory submissions with a thorough understanding of US and OUS regulations

  • Ability to manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines

  • Self-motivated, well organized, detail oriented, and has excellent written and verbal communication skills

  • Works under minimal direction and possess flexibility to work productively within an environment with evolving priorities and deadlines

  • Strong leadership skills and experience, a team player, a fully engaged, hands-on professional capable of working collaboratively and independently in a small-company environment