Job Description

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Responsibilities

The Director of Post Market Surveillance and Pharmacovigilance is responsible for overseeing post market surveillance, adverse events, recalls and pharmacovigilance for Cooper Surgical. Manages and oversees global initiatives as they impact the post-market surveillance activities for Cooper Surgical, and is responsible for the design, development, implementation, and maintenance of a compliant and effective post-market surveillance system. This may include communicating with the FDA for recalls, MDRs, periodic updates, pharmacovigilance, etc., and keeping senior leadership informed of post market feedback on Cooper Surgical products, services and processes. This role oversees the complaint handling process, is responsible for identifying and securing needed resources to ensure effectiveness, and successfully managing a team.

• Partner with Cooper Surgical senior management and site management to facilitate post-market surveillance across all locations.
• Partner with cross-functional team members to drive quality improvement activities and LEAN principles within the organization.
• Serve as the Cooper Surgical expert on post market surveillance activities, ensuring sites are supported through the decision-making activity, closure and termination of issues.
• Drive and establish robust and consistent evaluation methodology ensuring reporting of adverse events are consistently applied across all Cooper Surgical sites.
• Function as the subject matter expert on post market surveillance matters, including during external audits/inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).
• Drive continuous improvement and LEAN activities with sites to improve efficiencies in post market activities.
• Function as champion for IT projects impacting post market function and/or systems.
• Implement periodic post market surveillance review meetings to provide senior management with information regarding complaints and feedback from post market space.
• Oversee the complaint management team ensuring that all feedback mechanisms are captured and addressed in a timely manner.
• Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to capture post-market feedback.
• Ensure appropriate training is implemented company-wide for employees to understand the responsibilities for reporting customer complaints and the methods to communicate those complaints.
• Lead strategic planning, direction, and goal setting for the department or function.
• Instill a culture of continuous improvement by developing and implementing strategies that achieve measurable results.
• Manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality personnel as needed.
• Perform other duties as assigned.
  
  
  

Travel:

This position may require 10-15% domestic and/or foreign travel.

Qualifications

Knowledge, Skills and Abilities:

• Extensive knowledge of ISO 13485, FDA CFR 820, FDA CFR 806, FDA CFR 803, pharmacovigilance and emerging standards and regulations related to post market and vigilance activities.
• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management partnering across multidisciplinary teams (internal/external)
• Excellent situational analysis and judgement, able to provide guidance and counsel to site and staff throughout organization.
• Strong time management skills as an individual contributor and as a leader, able to drive individual/team projects to scheduled completion on time.
• Excellent team building and leadership skills, able to motivate team members to drive projects to successful conclusion, with the ability to manage and lead without direct authority.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
  
  
  

Work Environment:

• Prolonged periods of sitting, especially in front of a computer.
• Potential exposure to different manufacturing environments, necessitating adherence to varying safety protocols.
  
  
  

Experience:

• 10+ years total experience in the medical device industry
• 5+ years of experience managing Quality Assurance in the Medical Device Industry
• Experience in Post Market Surveillance required
• Experience with MS Word, Excel, Project Management and Analytics software
• Experience liaising with multiple international regulatory bodies and managing cross-cultural teams.
  
  
  

Education:

• Bachelor's degree in Health or Engineering field required; Advanced degree preferred.
• Professional affiliations in Quality Management preferred. Required licenses, if any, must be maintained and periodically renewed as needed.
  
  
  

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com