Regulatory Affairs Specialist II

Hologic Westford , MA 01886

Posted 6 months ago

At Hologic, we're an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

Summary

Cynosure, a Hologic Company, is seeking a Regulatory Affairs Specialist 2 to participates in product development teams. Handles complex submissions with minimal supervision. Organizes regulatory information and tracks and controls submissions. Reviews and advises on labeling for compliance with regulatory filings. Reviews product changes for impact on regulatory filings worldwide. Researches regulatory issues and provides guidance and advice to colleagues.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Completes submissions for countries that have complex requirements such as US FDA (510(k)s) Canada, China and/or Korea with minimal supervision.

  • Provide regulatory guidance to assigned product development team to insure the documents the team develops will meet the needs of the regulatory submissions.

  • Timely compile materials for license renewals, updates and registrations

  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners

  • Review labeling and labels for compliance with regulatory requirements

  • Review changes to existing products and SOPs to define the requirements for regulatory submissions

  • Provide the regulatory reviews of customer complaints and define the regulatory reportability

  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products

  • Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes

  • Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required.

  • Review of product complaints to determine if event is reportable.

  • Works with other departments (QA, Clinical, Service, and Engineering) to insure complete and accurate information in file.

  • Documents decision to report or not report event.

  • Prepares reports (MDRs, MDVs) for submittal.

  • Provide trend reports on adverse events as needed.

Qualifications

Education

  • BS or BA in engineering or scientific field.

Experience

  • 2-5 years relevant experience within the quality/clinical/regulatory discipline. 5-7 years without a degree

Skills

  • Knowledge of US and international medical device regulatory requirements

  • Experience with submitting 510(k)s is mandatory

  • Experience with electromechanical and/or software devices is a plus.

  • Strong understanding of design controls

  • International experience is required

  • Requires proficiency with standard software (Word, Excel, PowerPoint, etc.).

  • The ability to meet deadlines and be detailed orientated is necessary.

  • Excellent communication skills

  • Ability to manage multiple priorities

  • Requires creative, problem-solving ability and oral and written presentation skills

  • Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently.

  • Good planning and organization skills are vital.

  • Strong critical thinking and problem-solving skills

  • Effective verbal and written communication skills are essential.

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 inclusive of disability and veterans.


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Regulatory Affairs Specialist II

Hologic