Regulatory Affairs Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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JOB SUMMARY

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.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Cardiovascular

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats reimagining how we heal Our Cardiovascular team develops leading solutions for heart recovery electrophysiology and stroke. You will join a proud heritage of continually elevating standards of care for stroke heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Principal Automation Technician to be in Ciudad Juarez Salvarcar plant.

You will be responsible for:

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

• Requires 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

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