Vice President Regulatory Affairs & Quality Assurance
Hologic - Marlborough, MA

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Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, and treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, and mini C-arm for extremity imaging.
  • Coordinate submissions to FDA (510(k)s, PMAs, Annuals Reports, etc.)
  • Work with internal resources and FDA to determine least burdensome product approval strategies
  • Coordinate FDA required post-market surveillance programs
  • Develop and maintain department budget
  • Lead product field actions and/or recalls, as applicable
  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
  • Responsible for Company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide
  • Responsible for Company’s Quality Assurance to ensure product quality and reliability to meet or exceed customer expectations and to make quality competitive advantage
  • Assist in Clinical Studies required for Regulatory Approvals, including clinical study design, data analysis, and data reduction
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues
  • Represent the Company before regulatory authorities
  • Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities
  • Responsible for the review and approval of promotional, advertising, and labeling items
  • Assist in the Compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agencies
  • Directs activities of the Quality Assurance Department(s)
  • Assumes responsibilities of the Management Representative and as such chairs Management Review meetings
  • Leads and/or participates in multi-departmental and multi-site teams to implement quality strategies.
  • Reviews and approves document changes for Quality Assurance Departments as required.
  • Leads internal audit program
  • Oversees complaint handling program
  • Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry
  • Support Business unit management to meet their division objectives
  • Assumes responsibilities of the Management Representative and as such chairs Management Review meetings
  • Leads and/or participates in multi-departmental and multi-site teams to implement quality strategies
  • Reviews and approves document changes for Quality Assurance Departments as required
  • Leads internal audit program
  • Oversees complaint handling program
  • Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry
  • Support Business unit management to meet their division objectives

Hologic - 22 months ago - save job - copy to clipboard
About this company
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Hologic corporation is a developer, manufacturer and supplier of diagnostic and medical imaging systems related to women's health. It...