Director, Medical Affairs, Electrophysiology

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.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Irvine California United States of America

Job Description:

Johnson and Johnson is currently seeking a Director Medical Affairs Electrophysiology located in Irvine CA.

About MedTech Electrophysiology

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

The Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders Surgeons Regulatory Agencies Professional Societies etc.) to anticipate industry trends understand clinical/medical insights unmet medical needs and global standards of care to deliver quality products/solutions.

The Director Medical Affairs will:

• Work with business partners including but not limited to R&D Clinical & Pre-Clinical Research Regulatory Affairs Quality & Compliance Health Economics & Market Access and Professional Medical Education to influence overall regulatory and commercial strategy as well as support product development pre- and post-approval clinical studies downstream claims safety assessments and product launch.
• Lead the support for all clinical studies both for regulatory purposes as well as physician initiated collaborative studies. They will be responsible and accountable for case support plans and execution physician training internal field training training materials data analysis publication support and collection of data for supporting platform claims.
• Support the commercial launch of the platform by activating sites providing physician training to collect and provide regular feedback on product performance and improvements.
• Contribute to the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research.
• Participate in governance forums including Business Unit leadership teams cross-functional product core teams EGS teams portfolio/strategy management teams and Safety and Quality Review Boards.
• Engage Key Opinion leaders Professional Societies Payers and Providers to understand trends in care and uncover critical insights to support product innovation and HEMA needs.
• Provide support to Marketing R&D Communications Legal Quality Assurance/Risk Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities
• Collaborate with evidence generation colleagues from Preclinical Research and Clinical Research teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance health technology assessment customer access and post-marketing support
• Provide scientific expertise oversight and approval for clinical trial concept design analysis and reporting of clinical research in assigned areas
• Provide oversight for the development of materials to be used for study execution (investigator brochures training materials etc.)
• Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewed trended and escalated as needed
• Provide scientific input and expertise in the analysis of study results
• Work with Regulatory and Clinical partners to prepare report on clinical investigations in preparation for submission to regulatory agencies and/or for publication to meet evidence requirements
• Provide medical insights/expertise to the development teams for the risk assessment review for new products and reviews and approves the final risk management report for all new products
• Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals.
• Approve Design History Files Technical Guides and Clinical Evaluation Reports (CERs) as part of the creation of product-specific design dossiers/technical files
• Reviews and approves educational promotional and reporting materials for use by internal stakeholders. Strategizes and prioritizes publication proposals in collaboration with Clinical Science.
• Responsible for ensuring subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

Qualifications -

• Bachelors degree in Medicine Biomedical/Mechanical Engineering or equivalent life sciences/technical engineering discipline is required.
• Advanced degree MD PharmD or PhD in Medicine Biomedical Engineering or equivalent life sciences discipline is highly preferred.
• Previous Medical Affairs and/or Medical Science Liaison experience in a regulated commercial medical device business is strongly preferred
• Minimum 10 years of relevant business experience in product development within the Cardiovascular industry is required.
• A minimum of 3 years of relevant experience directly in Medical Affairs is required.
• Previous clinical experience in the electrophysiology space is highly preferred.
• Proven track record of the ability to learn complex technology/clinical applications is required.
• Minimum 10 years of experience supporting clinical cases and proctoring cases is preferred.
• Demonstrated success in medical data generation interpretation and publications is required.
• Excellent strategic thinking communication and stakeholdermanagement skills are essential.
• Strong knowledge of regulatory compliance and ethical requirements governing Medical Affairs activities is required..
• Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is required.
• Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is critical for success in this role.
• A proven ability to collaborate well with multiple partners and work effectively in a highly matrixed environment is required.

The anticipated base pay range for this position is $164000 - $305900.

At Johnson & Johnson were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through innovative programs and policies we empower the physical mental emotional and financial health of our employees and the ones they love! At Johnson & Johnson we offer a variety of outstanding health and financial benefits including competitive compensation 401k pension medical dental and vision insurance exercise reimbursement flexible time off paid volunteer and parental leave and more!

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

• Vacation 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
• Holiday pay including Floating Holidays 13 days per calendar year
• Work Personal and Family Time - up to 40 hours per calendar year
• Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave 80 hours in a 52-week rolling period10 days
• Volunteer Leave 32 hours per calendar year
• Military Spouse Time-Off 80 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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 our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via

Required Skills:

Preferred Skills:

Analytical Reasoning Business Requirements Analysis Clinical Research and Regulations Clinical Trials Operations Communication Developing Others Digital Culture Digital Literacy Healthcare Trends Inclusive Leadership Leadership Medical Affairs Medical Communications Medical Compliance Product Strategies Stakeholder Analysis Strategic Thinking Workflow Analysis

The anticipated base pay range for this position is :

$164000.00 - $282900.00

Additional Description for Pay Transparency:

Required Experience:

Director