Job Listing
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| Job ID: 14009687 |
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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 III |
| 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 III
About this role:
With adequate supervision, the Regulatory Affairs Specialist III is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.
Your responsibilities will include:
Support the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices.
Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts.
Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMA Supplements,510(k)s, Annual Reports, and CE Mark submissions under MDR.
Support international geographies to gain and maintain product approvals.
Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.
What we're looking for in you:
Minimum Qualifications
Bachelor's degree, minimum
3+ years of experience in Regulatory Affairs
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 30-day notices and annual reports and EU MDR technical documentation.
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
Team player with excellent interpersonal skills
Preferred Qualifications
General understanding of product development process and design controls
Working knowledge of FDA, EU, and international regulations
Ability to manage several projects
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Requisition ID:580456
Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Refer to ID 78876229 when applying |
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