Reg Affairs Specialist I Job at Boston Scientific Corporation
Posted in Compliance 21 days ago.
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Type: Full Time
Location: Minnetonka, Minnesota
Additional Locations: (n/a)
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges. Together, we re one global team committed to making a difference in people s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life s work.
At Boston Scientific, you ll discover a place where you can find meaningful purpose, improving lives through your life's work. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. This position is in the American Medical Systems (AMS) business of Boston Scientific which includes Men s Health and Prostate Health for treatment of urologic conditions, benign prostatic hyperplasia (BPH), male stress urinary incontinence and erectile dysfunction.
About the role:
This position's main contribution is to provide support to the regulatory function in order to drive competitive advantage and contribute to business results by improving the function's efficiency.
Your responsibilities will include:
* Support the integration of AMS by coordinating conversion of all labeling to BSC as the Legal Manufacturing under the MDD and subsequent submissions to all worldwide geographies.
* Support the Regulatory team with Technical File, Essential Requirements Checklist and Declaration of Conformity updates. Completes periodic review updates, reviews standard assessment references and supports conversion into latest Technical File template requirements.
* Assist with the regulatory strategy to transfer Technical Files under MDD to MDR prior to the 2020 transition date.
* Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
* Complete regulatory assessments for design and process changes and coordinates and manages Safety Net distribution controls as needed by completing request forms, and interacting with Master Data team to set up and define rules for all required Regulatory Safety Nets.
* Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
* Creates storage hierarchy and loads final Regulatory Submissions in Regis database
* Completes monthly entries for International reporting and submissions planning
* Assists the Regulatory team with UDI data entry and upload. Proficient in Excel to create, manage and coordinate required regulatory information fields for required device listings.
* May assist professional and technical staff with special projects.
* Provide data and information to other functions on processes and procedures, as requested.
* Uses software for functional area, to compile and generate reports, statistics, timelines, tables, graphs, correspondence and presentations.
* May design processes to enhance work flow.
* Provides data and information to others on functional unit processes and procedures.
What we re looking for in you:
* Bachelor s degree or equivalent combination of education and experience, preferably in a scientific or technical discipline
* 1+ years Regulatory Affairs experience, medical device company experience preferred
* Knowledge in specialized applications such as Regulatory Safety Nets, Legal Status controls, and Regis database preferred
* Proficiency with Microsoft Office, (i.e. creating formulas, v look up, pivot tables and working with multiple worksheets in Excel; using captions, cross references and inserting graphics, charts and tables in Word; creating forms, queries and reports in Access)
* General understanding of product development process documents, international standards and urology disease state products
* Ability to manage several projects
* Effective research and analytical skills
* Effective written and oral communication, technical writing and editing skills
* Ability to work independently with minimal supervision
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
Requisition ID: 400053
Nearest Major Market: Minneapolis
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