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The Director of Post Market Surveillance is responsible for developing, directing and managing Integra’s Global Post Market Surveillance Program. This includes Complaint Handling, Adverse Event Reporting, Health Hazard Evaluations (HHEs), Field Actions, and Post Market Surveillance activities required for EU MDR and other global regulatory bodies. This role will establish a Post Market Surveillance program that meets relevant procedures and external regulations and by giving quality issues the necessary attention to assist resolution. The Director of Post Market Surveillance will apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving post market issues across a matrix organization. This position will also work closely with Divisional management to establish and maintain quality and compliance standards globally, identify deficiencies and to develop and monitor corrective action plans, as necessary.

The Director of Post Market Surveillance partners with corporate, division and site leadership globally to ensure that post market surveillance activities are conducted in a way that meets relevant procedures and external regulations.

SUPERVISION RECEIVED

Reports directly to the Vice President of Global Quality Assurance and Post Market Surveillance

SUPERVISION EXERCISED

Manages a team of direct reports responsible for Complaint Handling, Adverse Event Reporting, Health Hazard Evaluations, Field Actions (Recalls), Post Market Surveillance Plans, and associated Post Market Surveillance Reports

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Maintain responsibility and accountability for the development, management and execution of PMS system policies, procedures, local work instructions, practices and compliance of complaint and AE reporting performance, working in a cross-functional team with other management/departments

• Lead the team to provide in depth analysis and expediting product complaints under the company's complaint procedures and ensuring compliance with federal regulations

• Chair Product Safety Board meetings, consisting of a team of Quality, Regulatory and Legal Chief Executives to present complaint and reporting trends, HHEs and Field Action recommendations.

• Ensure timeliness of reporting to FDA and other governmental agencies for post market activities.

• Responsible for ensuring post-market surveillance obligations are in accordance with the applicable regulations.

• Lead and direct the process for performing Health Hazard Evaluations (HHEs}, corrections, removals, (recalls) across all divisions and facilities, including maintaining responsibility for cross functional teams that evaluate product risk and potential safety issues. The teams will assess serious injuries and malfunctions in support of regulatory agency product surveillance requirements and ensure the timely initiation and completion of Health Hazard Evaluations (HHEs) and regulatory filings if applicable

• Proactively engage with all functions and levels of the organization globally to identify and alert of compliance in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.

• Lead the activities surrounding corrections and removals and ensure effective communication of all such activities to regulatory agencies.

• Hiring, developing, and organizing for the department such that the team meets all requirements in an efficient, process, and results oriented manner.

• Work closely with company personnel to ensure consistency in medical evaluations, the performance and documentation within HHEs and the product safety evaluations.

• Maintain responsibility for working in partnership with Design Quality Assurance (QA) in resolving customer issues and developing continuous process improvement initiatives.

• Work with management and Design QA to ensure field performance and safety issues are properly addressed for on-market product, new product requirements and/or risk management files.

• Work with various departments to gather post-market data to support documenting post-market surveillance reports / periodic safety update reports in accordance with regulatory requirements.

• Communicate with internal stakeholders and end users on complaint related issues.

• Oversee Trend Analysis on all complaints and reporting.

• Support management reviews and represent the company during compliance audits by external groups such as US FDA and notified bodies.

• Evaluate new regulations, guidelines and industry standards and their impact on all internal/external compliance matters; plan and effectively implement plans across the business to maintain compliance.

• Partner with sites to respond to FDA and other regulatory body audit observations as needed.

• Assure the organizational structure, processes, procedures, and resources for compliance are adequate to meet the needs of the business and conform to all applicable regulatory requirements (i.e., all adopted industry standards, Corporate Quality and Regulatory Compliance Policies, and with a broad range of medical device regulations including: FDA, ISO 13485:2016 Standard, European Medical Device Directives and Medical Device Regulation, Canadian Medical Device Regulations (CMDR), Japanese QMS Ordinance, Australian Therapeutic Goods (Medical Device) Regulations 2002 (No. 236) and other applicable regulatory agencies.

• All other duties and responsibilities as assigned

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

Education

•Bachelor’s degree

•10 years of demonstrated quality experience in the medical product and device industry with strong concentration in QSR and ISO 13485 compliance and quality assurance.

•Proficient understanding of medical device regulations which include complaint handling, adverse event reporting and recalls/FSCAs along with developing and leading a top performing team.

Skills/Knowledge

•Ability to travel domestically and internationally as business required.

•Experience with communicating with domestic and international regulatory bodies.

•Strong analytical, strategic, decision making, and risk assessment abilities.

•Highly developed technical writing and editing skills.

•Excellent organizational, leadership, and interpersonal skills.

•Thorough knowledge of product development process and design control.

•Knowledge of EU MDD / MDR, MDSAP, CMDR, PMDA/PAL, APAC Country requirements, LATAM

•Proficient in the following computer software applications: Microsoft Office

•Exceptional interpersonal skills.

•Strong organizational and communication skills (written and verbal).

•Ability to effectively communicate both internally and externally.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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