Vice President, Regulatory CSS

2 weeks ago

Austin, United States Integra LifeSciences Full time

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

The VP of Regulatory Affairs (RA) reports to the Corporate Vice President and Chief Regulatory Officer and identifies and directs communication to the company about emerging regulatory opportunities or issues that could impact the medical devices and other products sold by the company and in particular, the Codman Specialty Surgical business. The individual leads RA teams responsible for regulatory strategic planning primarily for the US and EU markets, but also supports international registrations for CSS products.

  • This individual is responsible for establishing and directing effective dialogues with the US FDA, EU notified bodies, and competent authorities, as well as other regulatory authorities as appropriate.

  • This individual provides leadership and mentoring to regulatory CSS team members and is responsible for hiring and developing CSS RA team members.

  • This individual is also responsible for leading the CSS regulatory team in developing the US and EU regulatory submission roadmap to facilitate timely registration and regulatory approvals.

  • While this role does not have primary responsibility for registrations outside the US and EU, this individual will be expected to work closely with the international RA and commercial teams to ensure international registrations for CSS products are supported by the CSS RA team as needed.

  • This individual prioritizes regulatory workload for the CSS regulatory team based on business initiatives and directs regulatory decisions that allow the company to achieve its goals, while maintaining global regulatory compliance.

  • This individual is a member of the Integra Global Regulatory Affairs Leadership team and Senior Management Team.

  • This individual is expected to participate in department wide initiatives including continuous improvement projects and other activities relevant to the entire department.

  • This position will oversee International RA personnel of Integra. This position will directly manage RA Director, Sr Manager, Manager, Regulatory Affairs Project Managers, Regulatory Affairs Specialist as required, as well as the Benelux site manager.


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

  • Providing leadership and mentoring to the CSS regulatory team by participating in career development programs and coaching RA teams members about best practices of an RA professional using Integra values as a guide;

  • Directing RA teams to ensure on time RA submissions and approvals;

  • Directing RA teams to ensure the company meets its goals while maintaining RA compliance;

  • Supporting the EU Authorized Representative and Person Responsible for Regulatory Compliance (PRRC) agreement responsibilities.

  • Preparation of the CSS RA annual budget and ensuring the CSS RA team operates within budget;

  • Preparing and directing the CSS RA team in project planning and project team assignment;

  • Participation in health Hazard evaluation and regulatory fields actions for the CSS business;

  • Providing oversight to CSS RA team and directing the development and approval of global RA strategies and regulatory plans for CSS products;

  • Directing and coordinating communication with the US FDA, EU notified bodies (if needed), competent authorities and other regulatory bodies.

  • Reviewing and approving labelling changes, promotional literature and marketing materials, rework of non-conforming products and CAPA closure.

  • Keeping apprised of new regulations, standards, policies and guidance documents issued by relevant regulatory authorities that may impact the company and coordinating communication to the company about relevant new regulatory intelligence that may impact CSS products.

  • Acting as CSS RA representative for Management review, Integrated Business plans review and new design reviews.

  • Leading teams as part of continual process improvement initiatives for the Integra Global Regulatory Affairs team;

  • Ensuring CSS RA and cross-functional teams are operating within company policy and procedures as they pertain to regulatory activities;

  • Participation in RA audits/ inspections as required;

  • Assisting in RA due diligence for company acquisition;

  • Writing and updating regulatory procedures and training key personnel as required; and

  • Performing other duties as assigned.


Qualifications

  • Bachelors, master's or PhD degree in science and/or Engineering

  • Minimum of 18 years of regulatory experience for a bachelor's degree holder with increasing responsibility in the medical device industry 11 to 13 years with master's degree or 8 to 10 years with PhD. At least 10 years' experience managing an RA team.

  • This individual must have proven ability to lead global RA teams responsible for coordination, planning, development and approval of RA submission documents.

  • Must possess and demonstrate an excellent understanding of the various regulations used in the US and EU.

  • This individual must have experience working with notified bodies, Competent Authorities and other RA agencies.

  • The individual must have strong project management, data analysis and written and verbal communication skills.

  • The individual must have the ability to handle multiple projects at a time.

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