Massachusetts Veterans Jobs

REGULATORY COMPLIANCE DIRECTOR - 00001JE6

Description

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Regulatory Compliance Director provides key strategic insight, direction, and oversight for all areas of Regulatory Compliance within Abiomed. 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. Can act as a delegate to the Sr. Director Regulatory Compliance.

JOB RESPONSIBILITIES

• Ensures compliance to standards, regulations, and internal policies. Responsible for implementing compliance strategies aligned with the MedTech and JJRC strategies.

• Leads processes, organizations, and governance to assure that compliance related requirements and goals for the MedTech Sites under responsibility are achieved. Provides innovative solutions to cross-functional compliance issues, assuring that the solution falls within appropriate regulatory guidance.

• May serves as a contributing member of the J&J MedTech 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.

• Ensure 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 MedTech 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.

• Organizational and people development. Develop 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. Develop 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 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 personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Qualifications

• 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

• 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

• 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

• This position required between 20-30 % of Domestic (US) and international traveling.

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.

Primary Location NA-US-Massachusetts-Boston

Organization Do not use (8535)

Job Function Compliance

Req ID: 00001JE6