Job Listing
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| Job ID: 13977020 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Regulatory Affairs Specialist, LAAC - IC |
| Work Type: | Work Days: Work Vary: Yes , Shift: Other, Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | Bachelor's Degree |
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| Experience Required: | Unspecified |
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| Required Skills: | Please see the job description for information about required job skills. |
| Preferred Skills: |
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| Job Description: |
Recruiter: Spencer Gregory Hale
Regulatory Affairs Specialist, LAAC - IC
About the role:
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist position supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio:
In this role, you'll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D and quality teams.
Key Responsibilities:
Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified products.
Provides technical reviews of test protocols and reports.
Assessment of labeling materials.
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.
Represents RA on cross functional project teams.
Participates in corporate and departmental training.
Assists International BSC Regulatory colleagues with international regulatory filings.
Works as liaison with International BSC Regulatory on various projects.
Minimum Qualifications:
BA/BS Degree in life sciences, engineering, or an equivalent.
1+ year of technical or medical device experience.
Ability to communicate complex ideas clearly and concisely (both verbally 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
Desired Qualifications:
1 year Regulatory Affairs experience
Preferred local candidate (hybrid work mode)
Requisition ID:578070
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Refer to ID 78335353_1 when applying |
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