Senior Regulatory Affairs Specialist - Heart recovery/Abiomed

Description

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.

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech

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

Abiomed is an innovative medical device company with an inspiring mission of “Patients First” and a unique guiding principle of “Recover Hearts.” Saving Lives.” With more than 3,000 employees, Abiomed is one of the fastest growing medical technology companies in the world, with headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer offering attractive working conditions and a rewarding corporate culture focused on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Position overview

As Senior Regulatory Affairs Specialist (m/f/d) you will be responsible for submissions in accordance with the European Medical Device Regulation (EU) 2017/745. The Senior Specialist will also support submissions to countries oriented towards CE marking (e.g. Eastern Europe, UK, CH, Middle East) as needed, as well as providing regulatory guidance to project teams. This role will preferably work a Flex/Hybrid schedule with 3 days per week on-site.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 https://www.jnj.com/medtech

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

Abiomed is an innovative medical device company with an inspiring mission of “Patients First” and a unique guiding principle of “Recover Hearts.” Saving Lives.” With more than 3,000 employees, Abiomed is one of the fastest growing medical technology companies in the world, with headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore. Abiomed is part of Johnson & Johnson MedTech.

Abiomed is an employer offering attractive working conditions and a rewarding corporate culture focused on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

We are searching for the best talent for our position in the Nord Rhein Westphalen area.

Key Responsibilities:

• Prepare and review Notified Body applications and other regulatory documents including Technical File / Design Dossier / STED submissions, Change Notifications and Periodic Medical Device reports as assigned

• Review and approve changes to manufacturing processes and products to ensure compliance with RA guidelines of assigned jurisdictions

• Provide input to the product development and engineering teams to ensure that RA requirements are understood as part of the product development and the engineering change process

• Communicate regulatory project status to internal stakeholders

• Support regulatory planning and alignment with business and functional goals and priorities

• Review and interpret regulatory rules as they relate to company products and procedures, testing or records keeping and ensure that they are communicated through company policies and procedures

• Support development and implementation of regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives

• Conduct presentations and negotiations to agency reviewers as needed

• Monitor changes of the regulatory landscape, identify impact to the company and support development of solutions to maintain regulatory compliance

Experience and Skills:

• Degree in Science, Engineering or IT, advanced degree preferred

• At least 5 years of regulatory affairs experience, preferably with a cardiovascular device company

• Solid experience and proven track record in successful submissions following Medical Device Regulation (EU) 2017/745

• Experience with submission of Medical Device software and hardware is a plus

• Experience with transfer of products from Medical Device Directive MDD 93/42/EWG to the Medical Device Regulation (EU) 2017/745

• Ability to communicate ideas and information clearly and effectively and frequently

• Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results

• Proficient in Microsoft Office Suite

• Fluent in English, and preferably in German

Die erwartete Basisvergütung für diese Position beträgt abhängig von Qualifikation und Vorerfahrung 75.000,00 EUR bis 118.450,00 EUR.

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