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 Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Aachen, North Rhine-Westphalia, Germany, Bonn, Germany, Cologne, Germany
Job Description:
About MedTech
Fuelled 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 talents will help to bring Impella heart pumps to more patients globally. 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, 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 in Aachen.
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 Documentation / 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
- Present to Notified Bodies regulatory strategies
- 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.
**Required Skills: **
Preferred Skills:
Coaching, Communication, Competitive Landscape Analysis, Compliance Management, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Product Packaging Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Researching, Safety-Oriented, Sustainability, Sustainable Packaging
The anticipated base pay range for this position is:
€75 000,00 - €118 450,00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.