Regulatory Affairs Specialist II

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: Irvine, California, United States of America

Job Description: Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II , MedTech Neurovascular.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

Job Summary 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.

Key Responsibilities: Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines: • 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.

• 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.

• Collaborates with others

• 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.

Experience and Education Required: BS with 2+ years of experience, or PhD, MS degree Preferred: Training in US and/or EU medical device regulations

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS . • 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

Additional position requirements • Preferred: Practical experience in a medical device regulatory environment

• Preferred: Practical experience working within a medical device quality system

• Preferred: Practical experience preparing submissions for Class II and III medical devices in the US and EU

• Language requirement: Proficiency in speaking, reading, and writing in English

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS Works with other departments such as Research and Development (R&D), medical affairs, clinical, Marketing, Supply chain and other functions to achieve bu

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