Compliance specialist Jobs in Roetgen

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 https : / / www.jnj.com Job Function : Regulatory Affairs Group Job Sub Function : Regulatory Affairs Job Category : Professional All Job Posting Locations : Aachen, North Rhine-Westphalia, Germany 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 looking for a Regulatory Affairs Specialist (m / f / d) to join the EMEA regulatory Affairs team in Aachen, or remote.

The Regulatory Affairs Specialist position will work closely with in country regulatory Affairs Representatives in the Asia Pacific and Middle East Region 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. Key Responsibilities :

• Create, maintain, and update relevant regulatory dossier / STED / database for product registrations, change notifications or annual report for Asia Pacific and Middle East 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. Qualifications
• Degree in Science or Engineering or Medical fields are required, advanced degree preferred.
• Have Regulatory Affairs experience in medical device Industry, preferably with a cardiovascular device company.
• Experience with regulatory submission of Class III Medical Device, preferred with Asia and Middle East.
• Ability to communicate ideas and information clearly and effectively and frequently.
• Scientific writing experience.
• Based in EMEA.
• Fluent in English, and preferably in one of Asia or Middle East languages, German is a plus.