Regulatory Affairs Manager in W. Lafayette, IN at Vaco

Date Posted: 5/4/2021

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/4/2021
  • Job ID:
    REGUL74376

Job Description

Provides leadership and guidance to the regulatory affairs team. Prioritizes and develops regulatory strategy and work content in gaining regulatory approvals, re-registrations, and changes to indications and product improvements to listed medical devices, with focused oversight of primary work content related to EU and US approvals/clearances. This may include generating new and/or maintaining/updating existing regulatory documents, including 510ks, IDEs, Design Dossiers, and CERs. Manages supporting regulatory staff.

  • Provide leadership and oversight over work content related to maintaining and obtaining regulatory clearances/approvals, including investigational Device Exemptions (IDEs), 501ks, Premarket Approvals (PMAs), design dossiers, Clinical Evaluation Reports (CERs), and other submission documents.
  • Author original regulatory documents for submissions in support of Class II and Class III medical device clearances/approvals.
  • Develop efficient regulatory processes to ensure regulatory compliance and maintenance of regulatory approvals.
  • Collaborate with other departments in all phases of the work process.
  • Mentor subordinates and other team members.
  • Provide well-reasoned and defendable positions on regulatory matters.
  • Represent Regulatory Affairs in cross-functional meetings.
  • Continually review processes for improvement and implements process improvements.

Job Requirements

Provides leadership and guidance to the regulatory affairs team. Prioritizes and develops regulatory strategy and work content in gaining regulatory approvals, re-registrations, and changes to indications and product improvements to listed medical devices, with focused oversight of primary work content related to EU and US approvals/clearances. This may include generating new and/or maintaining/updating existing regulatory documents, including 510ks, IDEs, Design Dossiers, and CERs. Manages supporting regulatory staff. Provide leadership and oversight over work content related to maintaining and obtaining regulatory clearances/approvals, including investigational Device Exemptions (IDEs), 501ks, Premarket Approvals (PMAs), design dossiers, Clinical Evaluation Reports (CERs), and other submission documents. Author original regulatory documents for submissions in support of Class II and Class III medical device clearances/approvals. Develop efficient regulatory processes to ensure regulatory compliance and maintenance of regulatory approvals. Collaborate with other departments in all phases of the work process. Mentor subordinates and other team members. Provide well-reasoned and defendable positions on regulatory matters. Represent Regulatory Affairs in cross-functional meetings. Continually review processes for improvement and implements process improvements.