What are the responsibilities and job description for the Senior Regulatory Affairs Program Lead (APAC) - Abiomed, Inc. position at Johnson & Johnson MedTech?
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:
Danvers, Massachusetts, United States of America
Job Description
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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 https://www.jnj.com/medtech
We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support the APAC unit of our Abiomed business. This role must be located within a commutable distance of Danvers, MA. This role will work a Flex/Hybrid schedule with 3 days per week on-site. There is NO remote option.
Purpose: This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission. In this role you will combine knowledge of scientific, regulatory, and business issues to enable products to meet the required legislation in the regions.
You Will Be Responsible For
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
Additional Description For Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Benefits
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 additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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:
Danvers, Massachusetts, United States of America
Job Description
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we’re 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 that’s 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 https://www.jnj.com/medtech
We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support the APAC unit of our Abiomed business. This role must be located within a commutable distance of Danvers, MA. This role will work a Flex/Hybrid schedule with 3 days per week on-site. There is NO remote option.
Purpose: This Senior Regulatory Affairs Program Lead position will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission. In this role you will combine knowledge of scientific, regulatory, and business issues to enable products to meet the required legislation in the regions.
You Will Be Responsible For
- Create, maintain, and update relevant regulatory dossier/STED/database for product registrations, change notifications or annual report for Asia Pacific Regions.
- Coordinate and follow up product registration in the regions and implement necessary approaches to speed up process.
- Prepare the relevant documentation in response to Health Authority inquiry.
- Support development and implementation of regulatory strategies throughout the product life cycle that are consistent with business unit goals and objectives.
- Use MDRiM to manage the regulatory project and communicate and regulatory project status to internal stakeholders.
- Provide input to the product development and engineering teams to ensure that international RA requirements are understood as part of product development and the engineering change process.
- Review and approve changes to manufacturing processes and products to ensure compliance with Review and approve changes to manufacturing processes and products to ensure compliance with RA guidelines of assigned jurisdictions
- Follow changes of the regulatory landscape in assigned countries, identify impact to the company and support development of solutions to maintain regulatory compliance.
- Minimum of a Bachelor’s Degree is required, Advanced Degree strongly preferred; Science, Engineering, or Medical fields highly desired.
- At least 6 years of relevant professional Regulatory Affairs experience in a highly regulated industry (4 with Advanced Degree); Medical Device and/or Cardiovascular strongly preferred.
- Experience with regulatory submission of Class III Medical Device highly desired.
- Experience with regulatory submissions with Asia and Middle East countries highly desired.
- Ability to communicate ideas and information clearly and effectively and frequently.
- Strong ability to work cross-functionally with R&D and Quality teams is required.
- Scientific/Regulatory writing experience required.
- Fluent in English, and preferably in at least one Asian languages (Korean, Japanese, Chinese) is a plus.
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
Additional Description For Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Benefits
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 additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Salary : $109,000 - $174,800