Medical Device, Quality/Risk Management, Submission & Registration
4 Year Degree
Would you like to work with the world's most advanced 3D mapping system?
Boston Scientific is looking for an experienced Senior Regulatory Affairs Specialist to work on RHYTHMIA, the only cardiac mapping system that enables true high-definition mapping.
Conveniently located for commuting in Metro Boston, next to the highway & public transit station, Boston Scientific’s Electrophysiology division will help you discover a place where you’ll have meaningful purpose, improving lives through your work with cutting-edge, industry-leading products.
More about RHYTHMIA:
The RHYTHMIA HDx Mapping System allows physicians to more clearly see and understand even the most complex arrhythmias. The system’s ability to create high-resolution maps using a novel algorithm has helped increase procedural efficiency and reduce the need for repeat ablation procedures.
Unlike conventional cardiac mapping systems, the RHYTHMIA HDx Mapping Systems offers the highest level of mapping efficiency by rapidly and automatically acquiring high volumes of data with improved electrogram resolution to generate three-dimensional maps of any chamber of the heart. The resulting maps are then used to help diagnose, locate and treat the source of rhythm abnormality. The system also improves the accuracy of the maps generated by using an intelligent annotation algorithm and a variety of therapeutic and diagnostic catheters that enable detailed and high-definition mapping and targeted ablation therapy.
The Senior Regulatory Affairs Specialist is responsible for planning, managing, composing, and submitting regulatory documentation to the FDA, Notified Body, and providing information for other country-specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Your responsibilities include:
Develops domestic and international strategies for regulatory approval of company products
Researches and advises company on country-specific international product registration and compliance related requirements
Coordinates, composes, compiles, and submits U.S., E.U. and international regulatory filings for new and modified company products, including 510(k)s, PMA supplements, IDEs, CE Mark technical files & design dossiers and updates, and provides information for other country-specific product registrations
Technical reviews of test protocols and reports and other submission deliverables for inclusion in regulatory filings
Assessment of labeling, advertising, and promotional materials for regulatory compliance and support of claims
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represents RA on cross functional product development and manufacturing support teams
Works with clinical affairs for reporting of A/E's associated with clinical trials
Assists with customer complaint, MDR, and field action-related tasks as assigned
Works on and/or leads complex regulatory projects as assigned
What we’re looking for:
BA/BS Degree in life sciences or engineering or an equivalent (Advanced Degree is a plus)
5+ years regulatory affairs experience
Specific experience in the planning, preparation, and submission of 510(k)s , Technical Files, and Design Dossiers is required. Experience in submitting Q submissions, Pre-IDEs, and IDEs is preferred. Experience in Class III U.S. submissions is a plus.
Demonstrated proficiency with relevant US/International regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Experience working directly with FDA, Notified Bodies and/or international health authorities is desired
Ability to communicate complex ideas clearly and simply both orally and in writing
Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
Team player with excellent interpersonal skills
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Ability to travel at least 15%
Additional Salary Information: Boston Scientific strives to provide compensation that is competitive in today's market and include competitive core benefits while differentiating ourselves with flexible options that meet individual needs.
Internal Number: 421529
About Boston Scientific
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran.