Sr. Manager, Regulatory Compliance - Shockwave Medical

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:
Procurement

Job Sub Function:
Category

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Manager, Regulatory Compliance - Shockwave Medical to join our team located in Santa Clara, CA.

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/.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

JOB SUMMARY

The Regulatory Compliance Senior Manager provides key strategic insight, direction, and oversight for all areas of Regulatory Compliance in Shockwave worldwide. Partners with leaders in R&D, Regulatory Affairs, Quality, Legal, Supply Chain, Clinical and Johnson & Johnson Regulatory Compliance to manage risk and ensure a strong regulatory compliance profile. Assures quality and compliance risk is identified and mitigated. Responsible for the Inspection Readiness, Inspection Management, and the Internal Audit program for all 3 (three) Shockwave Sites including Source Compliance. Supports the development and execution of remediation programs as needed. Supports the Integration Plan and New Product Introductions as JJRC member. Can act as a delegate to the Sr. Director Regulatory Compliance.

DUTIES & RESPONSIBILITIES

Under limited supervision, general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Ensures compliance to standards, regulations, and internal policies. Responsible for implementing compliance strategies aligned with the MDQ&C and JJRC strategies.
• Leads processes, organizations, and governance to assure that compliance related requirements and goals for the MD Sites under responsibility are achieved. Provides innovative solutions to cross-functional compliance issues, assuring that the solution falls within appropriate regulatory guidance.
• Can serves as a contributing member of the J&J MD Regulatory Compliance Leadership Team (LT) and an extended member of the Business Q&C LT and JJRC LT as delegated by the Sr. Regulatory Compliance Director.
• Manage relationships internally and externally and build cross-functional/departmental effectiveness.
• Develops and manages the Compliance budget as per the approved Business Plan.
• Ensures that a robust, efficient, and close loop internal audit program is executed per schedule by highly skilled compliance professionals.
• Support the sites in the development of corrective action plans to address observations. Monitor the effective and timely implementation of these corrective action plans.

• Develops and execute external inspection readiness plan for all sites.
• Ensures successful HA inspections, MDSAP certifications, notified body inspections, and readiness/transition for new regulations and standards.
• Partner with stakeholders (e.g., quality operations, source quality, franchise quality, quality systems, manufacturing, and other cross-functional business functions.) for the identification of potential quality or compliance issues and development of corrective action plans. Monitor the effective and timely implementation of these corrective action plans.
• Support the development and review of external Health Authority and notified body observation responses (appropriate response, investigation, corrective actions, timing, execution).
• Leads /Supports the Internal Compliance Academy to continuously improve the skills and capabilities of our workforce as it relates to Internal Requirements and External Regulations.
• As requested, supports the integration of acquisitions into the quality system including developing the audit program, inspection readiness, remediation, health authority/notified body relationship, certifications, and operationalization of new regulations & standards.
• Develops highly - skilled professionals capable of delivering current and future business needs, with special focus on new/emerging topics and compliance expertise (health technology, advanced mfg, robotics, technical documentation, etc.).
• Provides oversight and compliance review of remediation programs (MCAP/SDCAP/QEP, PAM, etc.).
• Provides periodic data and analytics to our business partners, including compliance data & current global health authority trends that enable the organization can deliver on quality and compliance commitments. Develops proactive approaches to address regulatory trends.
• Provides compliance advice and coverage for New Products, Acquisitions and Divestitures as needed.
• May participate as compliance advisor during PIE/PIA and RMB.
• May participate as compliance advisor during QRB as delegated by the Sr. Compliance Director
• Leads and supports efficiency and effectiveness initiatives as a continuous improvement to the JJRC Programs and Projects.
• Responsible for communicating business related issues or opportunities to next management level.
• 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.
• Responsible for ensuring compliance with all Federal, State, local and Company regulations, policies, and procedures as it relates to the QMS.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

• 10 years of related experience (Regulated Industry) and a bachelor's degree is required.
• Thorough technical knowledge of cGMPs/QSR, ISO13485, EUMDR, MDSAP and International regulatory requirements is required.
• Ability to effectively communicate requirements and regulatory issues.
• Goal oriented, focused on teamwork and the customer, ability to manage multiple projects, prioritize and adapt to business needs.
• Thorough understanding of business requirements
• Demonstrate proven leadership abilities and interdependent partnering, demonstrate conflict, and change management skills, the ability to influence and negotiate, possess strong decision-making and analysis skills, demonstrate organizational and people development and a track record of innovation and mastering complexity in projects.

• Build strong partnerships and connect regularly with key stakeholders and functional groups.
• Conduct open and transparent interactions with stakeholders. Proactively communicate potential quality and compliance risks
• Manage conflicts & focus on reaching effective solutions
• Look for pragmatic solutions that balance risk/benefits for both short- and long-term success.
• Be open to diverse opinions and ideas. Active listening
• Use influencing skills to drive the right actions and enable adoption of best practices
• Capable to interpret regulatory requirements in the light of current guidance and FDA/International regulatory body field activity.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES, and AFFILIATIONS

• Experience, supporting and managing Health Authority & Notified Body Inspections, managing internal audit program, expertise in ISO 13485, EUMDR, FDA CFR 820.
• Preferred certifications on the following: Certified Quality Auditor, Green Belt / Process excellence and project management.
• Excellent verbal and written communication skills, project management, problem solving, business/financial acumen, presentation skills, training/education methodologies, people leadership, talent development, etc.

Pay Transparency:

• The anticipated salary range for this position is $138,000 - $238,050
• 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)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
  
  • Vacation - up to 120 hours per calendar year
  • 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
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • 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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$138,00-$238,050

Additional Description for Pay Transparency: