Director, Post Market Surveillance

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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.

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 siteand 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:

• Bachelors 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 youll 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 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 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