# Temp. Regulatory Affairs Specialist 1 - 151951
Hologic, Inc\. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research\. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women\. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments\.
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\.
Hologic is seeking a **Regulatory Affairs Specialist 1** responsible for domestic and international regulatory activities associated with FDA, ISO, and international regulations\.
**Duties & Responsibilities:**
Support RA team in obtaining and maintaining approval to market IVD medical devices in worldwide markets\. This may include the following:
+ Participate, as directed, in new product development teams to coordinate preparation of regulatory content for domestic and international submissions for IVD medical devices \(CE, US, Australia, Canada, and other international markets\)\.
+ Involvement in the preparation of Pre\-Sub, FDA 510\(k\), PMA and PMA Supplement submissions
+ Complete reviews of design control documentation to ensure compliance with domestic and international regulatory requirements for IVD medical devices\.
+ Develop and execute submission strategies for assigned projects\. Monitor progress on key project deliverables and provide status updates on regular basis\.
+ Monitor and assess regulatory impacts of new and revised regulations, guidance, and standards\.
+ Support team’s daily operations such as change reporting assessments, complaint assessment for Vigilance/MDR, Recall, Field Safety Corrective Actions \(FSCAs\)\.
+ Develop and/or revise regulatory policies and procedures to keep current with constantly evolving regulatory and compliance environment\.
+ Prepare post\-market reports for marketed devices as required in the US and abroad\.
**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:
+ Demonstrated ability to coordinate complex projects\.
+ Strong oral and written communication and presentation skills
+ Very good analytical and problem solving skills\. Knowledge where to locate necessary information to guide regulatory inputs on complex topics\.
+ Strong understanding of how to work closely with cross\-functional stakeholders and apply regulatory science to complex technical and business challenges\.
+ Ability to decide most appropriate methods for executing assigned tasks\.
+ Solid working knowledge of the regulatory requirements related to pre and post\-market requirements for IVD medical devices in the U\.S\., Europe, Canada, Australia; additional experience with international registrations in emerging markets highly desirable\.
+ Understanding of U\.S\. and international regulatory policies affecting the Medical Technology industry\.
+ Demonstrate in\-depth understanding of advanced technical/scientific principles that related to laboratory automation, IVD reagent chemistry, and software components of IVD medical devices\.
+ Ability to build and manage positive relationships with internal and external customers \(e\.g\., other functions, international affiliates, Notified Body, reviewers, distributors, etc\.\)
+ Experience with IVDs a plus
+ Solid computer skills in Microsoft Office
**Education:**
+ Bachelors Degree required, preferably in engineering or life sciences\. MS or RAC preferred\.
**Experience:**
+ Minimum of 3\-5 years direct experience in regulatory affairs within an IVD or medical device manufacturing site\.
**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_
**Title:** *Temp. Regulatory Affairs Specialist 1*
**Primary Location:** *United States-California-San Diego*
**Organization:** *Regulatory %26 Quality Assurance*
**Schedule:** *Full-time*
**Shift:** *Day Job*
**Job Posting:** *Dec 31, 2015, 12:06:33 PM*
**Requisition ID:** *151951*