Senior Regulatory Affairs Program Lead (APAC) - Abiomed, Inc.

Johnson & Johnson Innovative Medicine•Danvers, MA

1d•$109,000 - $174,800•Hybrid

About The Position

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. 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.

Requirements

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.

Responsibilities

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.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year