Senior Director Regulatory Compliance, Abiomed, Shockwave, V-wave

JOB SUMMARY:

The Senior Director Regulatory Compliance provides key strategic insight, direction, and oversight for all areas of Regulatory Compliance within Abiomed, Shockwave, V-wave (MedTech) companies 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 the assigned Sites. Supports the development and execution of remediation programs as needed. Supports the integration of new acquisitions, due diligence, New Product Introductions as JJRC member. Serves as the Compliance Advisor when evaluation decisions related to product at Quality Review Board meetings (QRB). This role is responsible for all aspects of the new Above-Site Oversight program at Abiomed during the FDA remediation. This position will work closely with the Abiomed Remediation Lead. This individual is instrumental in helping to independently identify, escalate, and mitigate risks.

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 MT Q&C and JJRC strategies.
• Leads processes, organizations, and governance to assure that compliance related requirements and goals for the MT Sites under responsibility are achieved. Provides innovative solutions to cross-functional compliance issues, assuring that the solution falls within appropriate regulatory guidance.
• Serves as a contributing member of the J&J MT Regulatory Compliance Leadership Team (LT) and as extended member of the Business Q&C LT.
• Manage relationships internally and externally and build cross-functional/departmental effectiveness.
• Develops and manages the Compliance budget as per the approved Business Plan.
• Ensure that a robust, efficient, effective and close loop internal audit program is executed per schedule by highly skilled independent compliance professionals.
• Support the sites in the development of corrective action plans to address observations as needed. Oversees the effectiveness of the observations resolutions.
• Provides oversight to the development and execution of the 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, new product development, 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).
• Ensures the effective organizational and people development of the JJRC Team by ensuring direct reports are continuously exposed to new/emerging topics and compliance expertise (health technology, advanced mfg, cybersecurity, technical documentation, etc.) so that future business needs are adequately and compliantly served
• Provides oversight and independent compliance review of remediation programs (MCAP/SDCAP/QEP, SEA, PAM, etc).
• Provides periodic data analytics and insights to our business partners, including compliance data & current global health authority trends that enable the organization can deliver on quality and compliance commitments. Develop proactive approaches to address regulatory trends.
• Provides compliance expertise and coverage for New Products, Acquisitions and Divestitures.
• Primary participant as Compliance advisor during QRB meetings.
• Leads and supports efficiency and effectiveness initiatives as a continuous improvement to the JJRC Programs and Projects.
• Responsible for communicating business related risk and issues or opportunities to all levels of management.
• 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 personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION:

• 15 years of related experience (Regulated Industry) and a bachelor’s degree is required.
• Thorough technical knowledge of QMSR, ISO13485, EUMDR, MDSAP and International regulatory requirements is required.
• Ability to effectively communicate requirements and regulatory issues to all levels of management.
• 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
• Capability 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, preparing, supporting and managing Health Authority & Notified Body Inspections
• Expertise in ISO 13485, EUMDR, QMSR, MDSAP and other relevant Medical Device regulations and standards.
• Certified Lead Auditor
• Experience managing Internal Audit programs
• Experience supporting remediation programs
• Preferred certifications on the following: CMMI Lead Assessor, Green Belt certified/Process excellence and project management.
• Verbal and written communication skills, project management, problem solving, business/financial acumen, presentation skills, training/education methodologies, people leadership, talent development, etc.

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.