Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world.   Historically, Hologic developed, manufactured, and marketed products focused on mammography, breast care, and osteoporosis assessment.  Our core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. For more information visit www.hologic.com

Essential Duties and Responsibilities 

• 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

Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

• Regulatory Affairs Certified (RAC)
• Solid working knowledge of the regulatory requirements related to 21 CFR and European medical devices
• Skilled to read, analyze, and interpret data and review technical documents
• Excellent written and oral communication skills, capacity to communicate regulations to technical functions within the company

Education   

• Bachelor's Degree preferably in the science or legal areas

Experience  

• 10-15 years’ experience in Regulatory Affairs
• International and  Domestic Submissions experience
• PMA/510(k) devices and in-vitro diagnostics experience

Additional Details  

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an equal opportunity employer