Regulatory Affairs Administrative Assistant Job in Bedford 01730, Massachusetts Us
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
The Regulatory Affairs Administrative Assistant provides clerical and administrative support to Regulatory Affairs Quality Assurance Department. Assists in various companywide administrative activities.
Essential Duties Responsibilities
- Files correspondence, Device History Files and other records.
- Enters data into the Device History Database and the QC Database.
- Maintains Regulatory Quality documents and publications.
- Assists in copying and binding documents and reports for FDA submissions.
- Prepares correspondence and packages for mailing.
- Makes copies of correspondence and other printed matter.
- Maintains Journal Distribution Lists.
- Orders office supplies, arranges travel schedules and reservations, and assists in setting up meetings.
- Participates in mail and/or phone rotation.
- Complies with all GMP and ISO procedures.
- Request CFG from FDA, maintain inventory and distribute
- Assemble international registration documentation
- Create and maintain clinical data bases under direction of RA Manager
- Maintain RA filing library
- Make Travel arrangements as needed for staff members
- May include other duties as defined by the Function Head, Regulatory Affairs Quality Assurance
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.
- Good word processing skills, knowledge of Word, Excel, Power Point. Microsoft office
- Some knowledge of spreadsheets and database data entry.
- Detail orientated.
- Must be able to use hands for typing and be mobile to distribute mail.
- Able to use the telephone to talk with customers and other employees.
- Vision abilities required include: close vision, distance vision, depth perception and ability to adjust focus.
Education
- High school diploma with courses in business administration
Experience
- 3 years related experience OR equivalent combination of education and experience
Specialized Knowledge
- Knowledge of medical and regulatory terms a plus
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