Regulatory Affairs Specialist II

Johnson & Johnson MedTech · Irvine, CA · 3 days ago

RemoteRemoteLegal$76k–$122k/yrFull-time

About the Role

Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular. This role offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world. The position primarily supports regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets.

Responsibilities

Supports the preparation and compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies. Assists in responding to regulatory authority queries and deficiency letters. This includes but is not limited to 510(k), IDE, PMA, HDE, PMA/HDE Annual Reports, Technical Documentation Assessments, Design Examinations, Change Notifications (EU/UK), and other correspondence for new products and changes to existing products.
Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.
Reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.
Completes assigned duties in compliance with all international, federal, state, local, and company regulations, requirements, policies, and procedures.
Attends regular meetings with project teams for product development and product changes, communicating applicable regulatory requirements and activities needed to gain and maintain regulatory approval in various markets.
Collaborates with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agencies.
Communicates relevant technical and regulatory information to global partners to obtain local regulatory impact and to complete required regulatory submissions.
Provides Regulatory Affairs support for internal and external audits to comply with ISO 13485 and related standards.

Requirements

BS with 2+ years of experience, or PhD, MS degree.
Strong written and verbal communication skills, especially for conveying technical, scientific, and medical information in multiple technology formats and to different audiences.
Some knowledge of US and European regulatory processes.
Experienced in working as a member of a team.
Ability to communicate in a constructive manner to encourage new, diverse ideas so decisions can be made in alignment with business objectives and the J&J Credo.
Capability to work in an environment of innovative thinking, informed risk-taking, intellectual curiosity, and continual learning of regulatory developments.

Preferred Qualifications

Practical experience in a medical device regulatory environment.
Practical experience working within a medical device quality system.
Practical experience preparing submissions for Class II and III medical devices in the US and EU.
Training in US and/or EU medical device regulations.

Skills

Analytical Reasoning
Business Behavior
Business Writing
Collaboration
Communication
Confidentiality
Data Reporting
Data Savvy
Detail-Oriented
Execution Focus
Legal Support
Medicines and Device Development and Regulation
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments

Language Requirements

Proficiency in speaking, reading, and writing in English.

Schedule

Expected domestic and international travel: 5%–10%.

Pay

The anticipated base pay range for this position is $76,000.00 - $121,900.00.

Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Benefits

Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Consolidated retirement plan (pension) and savings plan (401(k)).
Vacation – up to 120 hours per calendar year.
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
Holiday pay, including Floating Holidays – up to 13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.