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Hologic Regulatory Affairs Specialist 2 in Marlborough, Massachusetts

Regulatory Affairs Specialist 2

Post Date Sep 25, 2020

Our PURPOSE—to enable healthier lives everywhere, every day—is driven by a PASSION to become global champions for women’s health. We succeed by fulfilling our PROMISE to bring The Science of Sure ® to life through product quality, clinical differentiation, customer relationships and our team’s talent and engagement.

Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this end, we offer clinically proven products designed to detect, diagnose and treat disease and other health conditions that primarily affect women—earlier and more accurately than ever to provide ever greater certainty and peace of mind. This focus has fueled our long track record of innovative medical breakthroughs across many therapeutic areas—breast health, cervical health, body composition, gynecologic health, perinatal health, skeletal health and sexual health—touching the lives of more than 230 million women around the world every year. In fact, as global champions for women’s health, no company in the world has done more to fight cervical and breast cancer than Hologic—and we will continue to challenge ourselves to ensure that future generations of women have access to our life-saving innovations.

Of course, none of this would be possible without the talent and passion of our employees. Together, our collective expertise and dedication to develop and market robust, science-based certainty sustain a pipeline of exceptional solutions that respond to the unmet health and wellness needs of women, families and communities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates sustainable global financial growth from which success and prosperity for our company, employees and investors naturally follow.

Job Summary

Responsible for regulatory activities associated with product registration and on market support of products in collaboration with Hologic partners worldwide. This position requires a person with commitment to excellence, fluent English verbal and writing skills, and ability to work in a fast-paced, technically skilled, team setting.

Essential Duties and Responsibilities

The incumbent may beasked to perform other function-related activities in addition to the belowmentioned responsibilities as reasonably required by business needs.

· Interact with business partners to support worldwide submissions for IVD medical devices (with an emphasis on China, Korea, Japan.)

· Develop and execute submission strategies for assigned projects. Monitor progress on key project deliverables and provide status updates on regular basis.

· Develop and/or revise regulatory procedures

· Provide regulatory support to existing and new cross-functional product core teams

· Review new product design protocols related to verification and validation, risk assessment, etc.

· Prepare, compile, and publish pre-market and post-market regulatory submissions for worldwide markets.

· Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark

· Assess manufacturing process, design, and labeling changes for regulatory reporting impact.

· Keep informed of new and revised regulations; disseminate information as appropriate.

Education and Experience

· Bachelor degree with 3 years of work experience or Masters with 2 years of industry experience in Regulatory/Quality Assurance/Clinical Affairs/ or Document Control.

· Demonstrated success with regulatory submissions to regulatory agencies [FDA, Health Canada, EU, AsiaPac countries].


· Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.

· Understanding of medical device and IVD regulations in US and international markets.

· Understanding of product life cycle process, design control and/or risk management.

· Proficient using Microsoft Office.

· Fluent English verbal communication skills and technical writing skills

· Chinese speaker a plus

· Ability to work as part of a cross-functional team.

· Ability to work and learn in a fast paced environment with shifting changes in prioritization based on regulatory and business needs.

· Ability to identify, understand, evaluate, and recommend solutions for complex regulatory problems.

· Ability to work effectively with teams with limited supervision.

· Ability to make and keep time bound commitments for project completion.

· Project management skills preferred

· Working knowledge of the medical device product lifecycle including product design and manufacturing change assessments for regulatory reporting.

Agency and Third PartyRecruiter 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 Employerinclusive of disability and veterans.