Regulatory Affairs Specialist II

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•$76,000 - $121,900•Onsite

About The Position

The Regulatory Affairs Specialist II position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world! The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets. This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as Technical Documents, amendments/supplements, annual reports, general correspondence, promotional materials, and other EU or US regulatory submissions. The individual will work closely with other Global Regulatory Affairs partners and with functional partners in Research and Development (R&D), Medical Affairs, Quality, Supply Chain, Marketing, and other functions.

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
Proficiency in speaking, reading, and writing in English

Nice To Haves

Training in US and/or EU medical device regulations
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

Responsibilities

Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters.
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.