Job Details

Senior-Regulatory-Affairs-Specialist

Company name
Hologic, Inc.

Location
Marlborough, MA

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Senior Regulatory Affairs Specialist','171093','!*!Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure.

There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.  Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.

We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. ','!*!A Senior Regulatory Affairs Specialist provides global Regulatory support to cross functional teams working on a range of products in Hologic’s GYN Surgical Solutions Division that include radiofrequency impedance-based technology, fluid movement, and electronics.  You will work in a multi-disciplinary group, contributing to the design, development and launch of Hologic’s innovative products that bring long-term positive change to patients and healthcare professionals.

Role

The Senior Regulatory Affairs Specialist provides medical device Regulatory Affairs expertise by participating in the day to day operations of the department as it relates to supporting business needs.

Essential Duties & Responsibilities

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.  

Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues

Participates in cross-functional teams to implement the regulatory strategies for the timely support of project team goals

Ensures that product development projects and changes to existing products are conducted in compliance with the appropriate regulations

Participates in document review process by reviewing documents for regulatory compliance

Prepares FDA submissions, which may include:  510(k)s, IDEs, IDE Supplements, PMAs, PMA Supplements

Prepares Canadian medical device submissions

Prepares technical files/design dossiers for European CE mark

Supports international registration activities

Interacts with domestic and international regulatory bodies and distributors

Reviews and approves promotional material to assure compliance to Regulatory requirements

Complies with all Quality System requirements

Reviews technical publications, articles and abstracts to stay abreast of regulatory developments in the industry

May include other duties as defined by Regulatory Affairs Management','!*!Qualifications  

Excellent writing skills with ability to write detailed information for submissions

Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations

Strong verbal skills including presentation skills

Strong interpersonal skills including the ability to interact with all levels of the company

Strong computer skills including Microsoft Office

Preferred Skills/ Qualifications

Excellent working knowledge of medical device regulations (21CFR) and FDA law

Solid working knowledge of the regulatory requirements related to European medical device directives; additional experience with international registration requirements highly desirable

Capacity to communicate regulations to technical functions within the company

Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)

Experience with document control systems such as Agile and Oracle

Medical device software submission and validation experience highly desirable

Certified regulatory affairs professional highly desirable

Education  

Bachelor’s degree (BA or BS) from a four year college or university in an engineering or science discipline (preferred)

Experience  

Minimum of 5 years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices

Additional Details  

There may be limited domestic or international travel

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 & VEVRAA Federal Contractor','United States-Massachusetts-Marlborough','','','','Regulatory and Quality Leadership','Full-time','Day Job','','Oct 10, 2017','Senior Regulatory Affairs Specialist

Company info

Hologic, Inc.
Website : http://www.hologic.com

Company Profile
Hologic, Inc. (Nasdaq: HOLX) is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women throughout the world

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