The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. In conjunction with other functions they support post market and provide lead external and Internal audits.

Primary Responsibilities:

• Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.

• Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements for New Product Development projects.

• Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.

• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.

• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact

• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.

• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, etc.).

• Perform other duties as assigned.

Qualifications

Minimum Requirements:

• Minimum of a Bachelor's Degree required; Advanced Degree strongly preferred.

• Minimum 3+ years related Regulatory Affairs experience, preferably within Medical Devices (2+ years with Advanced Degree).

• US FDA or Notified Body Submission experience strongly preferred.

• Knowledge or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance's and standards highly desired.

• Knowledge of orthopedic implants preferred.

• Familiarity with electronic submission preparation a plus

• Excellent written and oral communication skills

• Ability to handle multiple tasks, self-motivate and be detail oriented

The anticipated base pay range for this position is $89,000 to $143,750 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

o Vacation - up to 120 hours per calendar year

o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.