Staff Compliance Specialist

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 https://www.jnj.com

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• This position will be based fully on-site; one day a week remote can be accommodated.
  

THE OPPORTUNITY

The Staff Compliance Specialist - Regulatory Compliance for Johnson & Johnson Surgical Vision (JJSV) role offers a fantastic opportunity to play a pivotal role in ensuring compliance with regulatory standards that impact our industry-leading product portfolio. Based in Groningen, the Netherlands, this position is designed for a dynamic team member who thrives in a collaborative environment.

As Staff Compliance Specialist, you will lead the JJSV Groningen internal audit program to ensure quality system compliance against international regulations and standards such as FDA QSR, ISO, MDR, TGA, MDSAP, etc. You will have the chance to work closely with cross-functional teams to support external Health Authority inspections and Notified Body audits including readiness activities, front- and back-room participation/management, remediation plans, and general inspection support as needed.

About Vision

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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Key Responsibilities :

• Plan, coordinate, and conduct quality system audits of J&J Vision facilities and supportive activities for compliance as mandated by federal and international regulations and standards (e.g., FDA QSR, FDA cGMP, ISO, GCP) and Company requirements.
• Provide support to the JJV segment in the performance of audits or audit related activity.
• Provide regulatory assessments of audit findings and prepare appropriate reports to auditees and management following established procedures.
• Review and monitor required corrective actions, conduct follow-up activities on required action items.
• Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
• Providing support for FDA, Health Authority and Notified Body inspections conducted at J&J Vision locations, including readiness activities, front- and back-room participation/management and general inspection support as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.
• Consult with management, manufacturing, R&D, marketing company and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls.
• Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues.
• Develop and maintain key quality and compliance performance metrics. Participate in developing and presenting departmental materials for Management Review and Annual Product Reviews.
• Lead and/or participate on projects and initiatives, such as product design and development activities and operations/production initiatives, providing regulatory compliance guidance with regard to regulated products within the J&J Vision portfolio, including medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
• Partner with stakeholders and business partners to assess risk and establish proactive risk mitigation strategies and enable innovation in emerging areas.
• Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
  

IT’S ALL ABOUT YOU

To be successful, essential education and experience include:

• Bachelor’s degree, scientific discipline or equivalent.
• At least 4 years in the quality assurance / compliance audit environment.
• Minimum of 3 years of auditing experience
• Knowledge and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments.
• Proven track record of successfully facilitating external inspections.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Strong communication, organizational, negotiation and interpersonal skills.
• Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.)
• ASQ - CQA, CQE or SCQE, ISO Lead Assessor certification preferred.

Closing date: Sunday, 6th of July 2025.

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.