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JOB SUMMARY:

The Principal Regulatory Affairs Specialist is responsible for developing and authoring regulatory submissions (i.e., Q-Submissions, 510(k), IDE, and PMAs) and providing critical input on cross-functional project teams. The Principal Regulatory Affairs Specialist will develop and implement regulatory strategies to obtain timely approvals from regulatory authorities worldwide. This is accomplished by ensuring submissions are accurately prepared and comply with global regulations.

The Principal Regulatory Affairs Specialist will understand the regulations governing medical devices and will be responsible for assessing changes to medical devices and products or processes to determine the regulatory implications and performing regulatory activities to support implementing the device changes. Develops and maintains solid working relationships with other organizational functions (e.g., Quality Assurance, R&D, Sustaining Engineering, and Marketing) and will participate in new product development meetings and activities and support international and domestic registrations, including Technical Files.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified medical devices.
Assist in the development of the regulatory strategies for new products and design changes - ensuring regulatory requirements for target markets are met.
Preparing and submitting regulatory submission documents for US and OUS regulatory filings under minimal supervision for the EU and supporting outside of US (OUS) geographies.
Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
Prepare Technical Files /Design Dossier, Change Notifications, and Submissions (e.g. Documentary Audits under MDD/ MDR).
Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met before commercial release to maintain international product registrations.
Responsible for ensuring compliance with all relevant quality system regulations, including EU MDR Regulation, ISO 13485:2016, 21 CFR Part 820, and the Regulations applicable for MDSAP certification.
Prepare documentation that is complete, accurate, and on time.
Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
Actively participates in defining customer requirements, product claims, and target markets early in the product development lifecycle.
Participates in audits and inspections of the company and its quality systems.
Review marketing materials, go-to-market strategies, and other commercialization activities as required to ensure continued compliance with established product clearances; lead the development of the regulatory strategy for new claims and indications.
Support domestic and international field corrective actions and adverse event reporting.
Create and update departmental standard operating procedures (SOPs).
Perform all activities in compliance with the Quality System, ISO 13485, MDR, MHLW, CMDR, and all other applicable regulations to ensure all requirements are met.
All other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

Direct experience with preparing premarket documents such as 510(k), IDE, PMA, Technical File, and Design Dossiers.
Direct experience with preparing Pre-Submission and interfacing with FDA personnel.
Excellent knowledge and experience with global medical device regulatory requirements, design control, and product registration.
Working knowledge of product development process.
Ability to assess the changes to marketed products and their impact on product registration.
Ability to identify, research, analyze technical documentation, and interpret governmental regulations
Excellent oral and written communication skills.
Serve as regulatory liaison and work in cross-functional product development team.
Capable of handling multiple tasks/projects and managing priorities accordingly.
Works well under pressure in a dynamic timeline-driven environment.
Ability to work in a team environment and exert influence without alienating others.
Ability to work independently with minimal management oversight.
Under general supervision, works within established guidelines and has the flexibility to manage, and prioritize job duties. This position requires a significant amount of initiative and judgment.
Extensive experience with MS Word and EXCEL.
Regulatory Affairs Certification (RAC) preferred.

EDUCATION AND EXPERIENCE:

Bachelor’s degree in chemistry, scientific or engineering discipline
4+ years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry
Experience in regulatory submissions (i.e. writing/developing/preparing/creating submissions for medical devices (Q-Submission, 510(k), IDE, PMA, Technical File, Design Dossier).

PHYSICAL REQUIREMENTS:

Must be able to remain in a stationary position for at least 50% of the time, including sitting at a desk and working on a computer.
Occasionally move about inside the office and travel to and from office buildings. This may include but is not limited to, bending and walking.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, a computer keyboard, a calculator, etc.
Occasionally lift up to 15 pounds. This may be performed with reasonable accommodation.
View and type on computer screens for long periods.

This description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned.

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Orange County Regulatory Affairs Discussion Group (OCRA)

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Principal Regulatory Affairs Specialist