Regulatory Compliance Specialist Coop

Key Skills

Business Analytics, Data Analytics, Data science techniques, Management, Microsoft-Excel, Tableau

Job Description

At Johnson & Johnson , we use technology and the power of teamwork to discover new ways to prevent and overcome the world’s the most significant healthcare challenges. Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines. We're disrupting outdated healthcare ecosystems and infusing them with transformative ideas to help people thrive throughout every stage of their lives. With a reach of more than a billion people every day, there’s no limit to the impact you can make here. Are you ready to reimagine healthcare?

Here, your career breakthroughs will change the future of health, in all the best ways. And you’ll change, too. You’ll be inspired, and you’ll inspire people across the world to change how they care for themselves and those they love. Amplify your impact. Join us!

Ethicon Regulatory Compliance Overview

Ethicon Regulatory Compliance has compliance oversight at the various Ethicon sites in J&J. The compliance team supports the sites in ensuring that each site is complying with applicable regulations and directives such as 21 CFR 820, 21 CFR 4, ISO 13485/EN ISO 13485, ISO 14971/EN ISO 14971, European Medical Device Directive and European Medical Device Regulation, Canadian Medical Devices Regulations SOR/98-282, ANVISA Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products RDC 16/2013, Japan Ministry of Health, Labour and Welfare of Japan Ordinance No. 169, Australia Therapeutic Goods (Medical Devices) Regulations, and any other regulations or standards applicable to the site. The team runs the Internal Audit program and other compliance programs for the sites ensuring that sites are following requirements from internal Standards, procedures and external regulations and directives outlines above. Regulatory compliance metrics and data analytics for Medical Device sector is also managed and maintained by the compliance team and is key to identify areas of opportunity and improvement within our business. Our technologically advanced corporate environment focuses on developing individual engineering, business, and technical/scientific skills.

Co-op Expectations/Responsibilities/Project Details

Be part of a team responsible for the management of Internal and External audits, and maintenance of the Medical Device compliance metrics.

Opportunity to learn and have in-depth knowledge in Medical Device Regulations and Directives

Opportunity to participate in Internal and External audits to learn auditing skills and understand the dynamics of auditing.

Follow up on audit actions to completion/closing

Actively participate in monthly metrics data analytics and interact/network with management.

Participate in compliance projects as needed.

• The anticipated base pay for this position is between $22.75 and $29.00, but will be based on candidate’s program year, field, degree and/or experience.

Qualifications

• Candidates must be legally authorized to work in the U.S. and must not require sponsorship for employment visa status now, or in the future (ex. H1-B, F-1)
• Candidate must be actively enrolled in an accredited University for the duration of a co-op assignment pursuing a Bachelor’s, Master’s and/or MBA (preferred)
• Ability to demonstrate strong analytical and quantitative skills is required
• Intermediate to Advance knowledge of Excel (using programming) and initial knowledge of other data packages (e.g., Tableau)
• Excellent communication, presentation skills and leadership skills are preferred
• Desired Majors :

  Data Analytics related: e.g.- Majors in Data Science, Business Analytics

  Engineering

  Computer/ Software / Systems Engineering

• Available to work on site.
• Ability to balance multiple projects and initiatives while executing results
• Must be a self-starter who works independently while contributing to the team goals
• Expected to provide your own transportation to and from the work location Raritan NJ