Jnjmedtech
Senior Director, International Regulatory Affairs
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.
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Job Summary The Senior Director, International Regulatory Affairs works closely with internal departments and partners to effectively manage regulatory requirements for Shockwave Medical products. This role combines scientific, regulatory, and business expertise to ensure products are developed, manufactured, and distributed in compliance with regulatory requirements worldwide. It functions independently as a decision-maker on regulatory issues, guarantees that submission/registration/renewal deadlines are met, supports new product development, and communicates and negotiates with product teams, domestic Regulatory leadership, and external stakeholders.
Responsibilities
Collaboratively interface with various levels and coordinate activity across organizational units.
Manage, mentor, and develop direct reports to meet individual and company goals.
Develop, follow, and train key personnel on regulatory policies, processes, and SOPs.
Develop and implement regulatory strategies and update them based on regulatory changes.
Determine submission and approval requirements in assigned geographies and develop work plans/delegate assignments to the team.
Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development, and operations teams.
Work with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, relevant sections of 21 CFR, regulatory agency guidance documents).
Effectively write and edit technical documents.
Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
Provide guidance to functional groups in developing relevant data to complete a regulatory submission.
In collaboration with cross‑functional team members, direct the team in approval strategy development, compilation, preparation, review and submission of regulatory submissions to authorities outside the US and EU (e.g., China, Canada, Latin America, Middle East, Asia Pacific).
Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
Effectively communicate application progress and solutions to internal stakeholders through directors.
Direct directors and managers in preparing and maintaining annual licenses, registrations/listings for assigned geographies.
Support product safety evaluation and reporting (e.g., Medical Device Reporting/Vigilance) as required by country regulation.
Provide regulatory input for product recalls and recall communications.
In collaboration with Regulatory leadership, develop, communicate, and build consensus for regulatory goals aligned with company goals.
Review and approve advertising and promotional materials to ensure regulatory compliance in all appropriate geographies.
Evaluate and provide guidance on import/export requirements implementation.
Identify emerging issues and regularly communicate status and collaborative solutions as appropriate.
Qualifications
Minimum 12 years’ experience in a regulated healthcare industry with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 7 years experience; or equivalent experience.
Degree in science, math, engineering, medical or other technical fields and Class III medical device experience preferred.
Minimum 5 years’ prior management experience preferred.
Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
Strong understanding of and experience with pre‑ and post‑market medical device regulations, requirements and submissions.
Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
Analytical thinking with excellent problem‑solving skills.
Effective negotiation skills internally and externally with regulatory agencies.
Sound and ethical judgment in accordance with company policies and regulations.
Clear verbal and written communication skills with diverse audiences.
Knowledge of business functions and cross‑group dependencies/relationships.
Strong organization and time‑management skills, including the ability to prioritize multiple challenging project timelines in a fast‑paced environment while ensuring collaboration and accurate submissions.
Leadership of functional groups in identifying data needs and developing relevant data for regulatory submissions.
Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Positive, flexible leadership of direct reports in dynamic environments.
Travel up to 20% international & domestic.
Location Remote (US) – available in all states. Examples of reference locations include Santa Clara, California.
Benefits and Pay Anticipated base pay range: US: $173,000‑$299,000. Bay Area (CA): $238,000‑$382,000. Eligible for an annual performance bonus and long‑term incentive program. Participation in company‑sponsored benefits (medical, dental, vision, life insurance, disability, accident insurance, legal insurance, retirement plan, 401(k)).
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you have a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or contact AskGS for accommodation resources.
#J-18808-Ljbffr
Learn more .
Job Summary The Senior Director, International Regulatory Affairs works closely with internal departments and partners to effectively manage regulatory requirements for Shockwave Medical products. This role combines scientific, regulatory, and business expertise to ensure products are developed, manufactured, and distributed in compliance with regulatory requirements worldwide. It functions independently as a decision-maker on regulatory issues, guarantees that submission/registration/renewal deadlines are met, supports new product development, and communicates and negotiates with product teams, domestic Regulatory leadership, and external stakeholders.
Responsibilities
Collaboratively interface with various levels and coordinate activity across organizational units.
Manage, mentor, and develop direct reports to meet individual and company goals.
Develop, follow, and train key personnel on regulatory policies, processes, and SOPs.
Develop and implement regulatory strategies and update them based on regulatory changes.
Determine submission and approval requirements in assigned geographies and develop work plans/delegate assignments to the team.
Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development, and operations teams.
Work with product development, quality, and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, relevant sections of 21 CFR, regulatory agency guidance documents).
Effectively write and edit technical documents.
Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
Provide guidance to functional groups in developing relevant data to complete a regulatory submission.
In collaboration with cross‑functional team members, direct the team in approval strategy development, compilation, preparation, review and submission of regulatory submissions to authorities outside the US and EU (e.g., China, Canada, Latin America, Middle East, Asia Pacific).
Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals.
Effectively communicate application progress and solutions to internal stakeholders through directors.
Direct directors and managers in preparing and maintaining annual licenses, registrations/listings for assigned geographies.
Support product safety evaluation and reporting (e.g., Medical Device Reporting/Vigilance) as required by country regulation.
Provide regulatory input for product recalls and recall communications.
In collaboration with Regulatory leadership, develop, communicate, and build consensus for regulatory goals aligned with company goals.
Review and approve advertising and promotional materials to ensure regulatory compliance in all appropriate geographies.
Evaluate and provide guidance on import/export requirements implementation.
Identify emerging issues and regularly communicate status and collaborative solutions as appropriate.
Qualifications
Minimum 12 years’ experience in a regulated healthcare industry with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 7 years experience; or equivalent experience.
Degree in science, math, engineering, medical or other technical fields and Class III medical device experience preferred.
Minimum 5 years’ prior management experience preferred.
Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
Strong understanding of and experience with pre‑ and post‑market medical device regulations, requirements and submissions.
Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
Analytical thinking with excellent problem‑solving skills.
Effective negotiation skills internally and externally with regulatory agencies.
Sound and ethical judgment in accordance with company policies and regulations.
Clear verbal and written communication skills with diverse audiences.
Knowledge of business functions and cross‑group dependencies/relationships.
Strong organization and time‑management skills, including the ability to prioritize multiple challenging project timelines in a fast‑paced environment while ensuring collaboration and accurate submissions.
Leadership of functional groups in identifying data needs and developing relevant data for regulatory submissions.
Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Positive, flexible leadership of direct reports in dynamic environments.
Travel up to 20% international & domestic.
Location Remote (US) – available in all states. Examples of reference locations include Santa Clara, California.
Benefits and Pay Anticipated base pay range: US: $173,000‑$299,000. Bay Area (CA): $238,000‑$382,000. Eligible for an annual performance bonus and long‑term incentive program. Participation in company‑sponsored benefits (medical, dental, vision, life insurance, disability, accident insurance, legal insurance, retirement plan, 401(k)).
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you have a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or contact AskGS for accommodation resources.
#J-18808-Ljbffr