Manager, Standards Compliance

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raynham Massachusetts United States of America

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 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.

DePuy Synthes is recruiting for a Manager Standards Compliance located in Raynham Massachusetts.

Job Overview

The Manager Standards Compliance provides subjectmatter expertise to ensure regulatory compliance and safe use of materials and chemicals across the product lifecycle. This role supports global product stewardship activities by interpreting and applying chemical material and environmental regulations enabling compliant product development manufacturing and commercialization. The position plays a critical role in managing regulatory risk supporting sustainability objectives and partnering crossfunctionally to ensure continued market access for DePuy Synthes products.

Key Responsibilities

• Serve as a subjectmatter expert for product stewardship related to materials and chemicals supporting regulatory compliance activities.
• Interpret and apply global regional and local chemical and material regulations (e.g. substance restrictions disclosure requirements) to products and processes.
• Provide regulatory and technical guidance on material composition chemical compliance and product safety assessments.
• Partner with Regulatory Affairs Quality R&D Supply Chain and Sustainability teams to support product lifecycle decisions.
• Support regulatory submissions responses and documentation related to materials and chemical compliance.
• Monitor evolving chemical and material regulations and assess potential business and product impacts.
• Support internal and external audits inspections and compliance assessments related to product stewardship.
• Drive continuous improvement initiatives to strengthen product stewardship processes data quality and compliance governance.

Qualifications

Education:

• Bachelors degree in Chemistry Materials Science Engineering Regulatory Affairs Environmental Science or a related discipline (required).
• Advanced degree in a scientific or regulatory field (preferred).

Experience and Skills:

Required:

• Typically 6-8 years of progressive experience in product stewardship regulatory affairs materials compliance or chemical compliance within a regulated industry.
• Strong knowledge of chemical and material regulatory requirements and product stewardship principles.
• Experience interpreting regulations and applying requirements to products and manufacturing processes.
• Ability to analyze complex material and chemical data and communicate impacts clearly to stakeholders.

Preferred:

• Experience in medical devices healthcare or other highly regulated industries.
• Familiarity with global chemical regulations and reporting requirements.
• Experience supporting regulatory audits or inspections related to materials or chemical compliance.
• Experience working in a global or matrixed organization.
• Demonstrated experience driving product stewardship or compliance process improvements.
• Excellent analytical documentation and problemsolving skills.
• Strong collaboration and stakeholder management skills in a crossfunctional environment.

Other:

• Language: English required.
• Travel: Limited; occasional domestic or international travel.
• Certifications: Regulatory Affairs Certification (RAC) or relevant chemical/compliance certifications preferred but not required.

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Required Skills:

Preferred Skills:

Business Alignment Coaching Collaborating Compliance Management Continuous Improvement Fact-Based Decision Making Good Manufacturing Practices (GMP) ISO 9001 Process Improvements Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Regulatory Environment Standard Operating Procedure (SOP) Tactical Thinking Technical Credibility

The anticipated base pay range for this position is :

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Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave 80 hours in a 52-week rolling period10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per calendar year For additional general information on Company benefits please go to: - Experience:

Manager