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:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Grecia, Costa Rica

Job Description:

"Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.”

About Orthopedics

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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

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

We are searching for the best talent for Regulatory Compliance Manager to support our MedTech Orthopedics business​ in Grecia, Costa Rica.

Purpose:

The Regulatory Compliance Manager’s primary responsibility is to provide site support to assess and monitor the compliance to regulations and standards applicable at the site including but not limited to; FDA QSR, MDD/MDR, and ISO compliance. This is primarily accomplished by directing routine and special request internal compliance audits whose outcomes are documented and reported to responsible company management. This individual is to serve as primary or alternate liaison to FDA and/or Notified Body officials during audits of the site.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Under limited supervision and in accordance with all applicable federal, state and local

laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Lead site specific audit readiness activities.
• This individual will also be the point of contact for implementation of Johnson & Johnson standards at the local facility level.
• Direct and/or conduct internal and external audits against FDA 21 CFR Part 820, ISO13485, EU.
• MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia, TGA, ther applicable regulatory standards and J&J Standards across the J&J Med Tech CR organization.
•  Provides necessary support if responses are required to Regulatory Authorities.
• Create and provide audit-related metrics for the site Management Reviews and monthly QPR. This includes collection of internal and external audit observations, action status and plans.
• Support enterprise-wide training such as Good Documentation Practices, Data Integrity, New Hire Training, ISO 13485:2016, MDSAP, Audit Preparedness, customized to site-specific needs.
• Provide audit results to management and coordinate audit CAPA/OBS actions.
• This individual will direct and/or conduct investigations into potential quality/compliance
• Keep management informed of issues.
• He/she will provide consulting service to site personnel.
• Stay current on applicable industry and country requirements. Monitor external publication sources for issues applicable to
• This individual will be required to know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Participate in our compliance program-related activities as denoted by the organization.
• He/she will promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
• Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to appropriate personnel.
• Perform additional duties as assigned.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• University Bachelor’s degree in engineering, Chemistry, Biology, Life Sciences, Quality or an equivalent technical degree is required. Master’s degree Preferred.
• A minimum of 6-8 years quality/compliance experience in the medical device and/or pharmaceutical industry is required. · A minimum of 3 years of experience directly performing audits in the medical device and/or pharmaceutical industry is required. · Direct contact/interaction experience with the FDA, ISO registrars and other notified bodies is required. · Experience working with Manufacturing, Product Development, and corporate functions is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES

• Auditor certification such as ASQ Certified Quality Auditor (CQA) preferred
• Documented training in FDA Quality System Regulation (QSReg/QMSR), ISO 13485 and the
• MDD/EUMDR/ MDSAP is preferred.
• Stakeholder management.
• Leadership and management skills.
• Excellent communication and interpersonal relation skills.
• Regulatory compliance knowledge and skills.
• Advanced Quality Systems knowledge.
• Interpretation and application of QSR, ISO Standards and other relevant global regulations.
• Advanced computer and use of software application(s).
• Coaching skills.

 

 

Required Skills:

 

 

Preferred Skills:

Audit and Compliance Trends, Coaching, Compliance Management, Compliance Policies, Confidentiality, Consulting, Controls Compliance, Developing Others, Internal Auditing, Investigation Techniques, Legal Function, Legal Services, Policy Development, Process Improvements, Risk Compliance, Tactical Planning, Technical Credibility