Vigilance Specialist

at  Johnson Johnson

Johnson & Johnson is currently seeking a Vigilance Specialist to join our team at Biosense Webster, Inc., located in Diegem, Belgium.
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/.
Are you passionate about making a difference in the lives of individuals with cardiac arrhythmias? Join us as a Vigilance Specialist, where you’ll play a key role in ensuring high levels of customer satisfaction and regulatory compliance in a dynamic environment. This role offers a unique opportunity to contribute to impactful vigilance activities while working within a supportive and diverse team.

What you will be doing:

• Complaint Management: Review and process product complaints, ensuring adherence to both internal and external procedures and regulations.
• Regulatory Reporting: Make regulatory reporting determinations and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant regulations.
• Investigation Support: Facilitate and oversee complaint investigations, including creating follow-up questions and coordinating with other sites.
• Audit and Compliance: Support regulatory audits, compliance reviews, and maintain a thorough understanding of quality system policies and procedures.

What impact you will also have:

• Customer Satisfaction: Enhance responsiveness and satisfaction for both internal and external stakeholders.
• Regulatory Adherence: Ensure timely and accurate reporting in line with European and other international guidelines.
• Team Development: Participate in the onboarding and training of new associates, contributing to a knowledgeable and efficient team.
• Continuous Improvement: Engage in projects and process improvements that align with our business goals and quality expectations.

QUALIFICATIONS

We would love to hear from you if you have the following essential requirements:

• Bachelor’s degree in Biomedical Science or a related field preferred.
• 2-3 years of experience in a regulated medical device or clinical environment.
• Proficiency in English, both oral and written!
• Strong computer skills for data evaluation, regulatory reporting, and correspondence.
• Experience in pharmacovigilance, medical device vigilance, or nursing preferred.

What’s in it for YOU:
Competitive salary and benefits package including lunch card, wellness allowance, and employee discounts.
Flexible work options and work-from-home opportunities.
Professional development with training allowances and career growth opportunities.
Generous holiday days and share incentives.
What type of mark will YOU make?
By joining Johnson & Johnson, you will find boundless opportunities to craft your path and amplify your impact inside and outside our walls. With our commitment to being the world’s healthiest workforce, you can strengthen both your body and mind. At Johnson & Johnson, your talent can touch over a billion lives worldwide every day. Apply your skills to our collective purpose and make a lasting impact—because together, we can change everything.
Diversity, Equity & Inclusion at Johnson & Johnson means “YOU belong”!
For more than 130 years, diversity, equity, and inclusion have been integral to our cultural fabric at Johnson & Johnson. Our commitment to respecting the dignity and diversity of all is embedded in our Credo. We strive to create an inclusive environment where diverse perspectives and experiences are valued, and every individual feels they belong and can reach their full potential. Join us in building a workforce that reflects the diverse markets we serve and fosters a culture of belonging

• Complaint Management: Review and process product complaints, ensuring adherence to both internal and external procedures and regulations.
• Regulatory Reporting: Make regulatory reporting determinations and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant regulations.
• Investigation Support: Facilitate and oversee complaint investigations, including creating follow-up questions and coordinating with other sites.
• Audit and Compliance: Support regulatory audits, compliance reviews, and maintain a thorough understanding of quality system policies and procedures