Prin Reg Affairs Specialist Job
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POST DATE 9/18/2016
END DATE 10/9/2016
Boston Scientific Corporation
JOB DESCRIPTIONPRIMARY LOCATION: US-CA-Fremont
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 283801
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.
The Principal Regulatory Affairs Specialist will prepare a full range of Global regulatory strategies and the corresponding documents for submission, review and approval by FDA and EU Notified Body.
- Fully support the Quality Policy by building quality into all aspects of my work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for my position and documenting that training).
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
- Filings include 510k, IDE, letter-to-file, and Notice of Change
- Schedules, plans and conducts meetings with Office of Device Evaluation as required.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- Plans and coordinates implementation of validation strategies and schedules with Engineering, Clinical Research and Quality Assurance personnel, for multiple project teams.
- Develops and implements departmental and divisional policies and procedures.
- Supports the creation of written company standards and policies to support ISO 13485, including the creation of technical files, design dossiers and CE Marking.
- Reviews and approves design, manufacturing process, engineering change requests.
- Assists with regulatory inspections by FDA investigators or Notified Body auditors.
- Shares responsibility and authority for maintaining GMP and ISO compliance throughout the organization.
- Develops and implements regulatory strategies for new and modified products.
- 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.
- Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
- Supports highly technical or major business segment product lines, special projects or strategic initiatives.
- Other duties as assigned.
- Bachelor's degree in a scientific or technical discipline required; advanced degree preferred
- 8+ years Regulatory Affairs medical industry experience required; specific medical device experience preferred
- Working knowledge of regulatory strategies/requirements of capital equipment (including software related requirements) is desirable
- RAC certification preferred, not required
- Working knowledge of FDA, EU and international regulations
- General understanding of product development process and design control
- Ability to manage several projects within assigned timelines
- Proficiency with Microsoft Word, Excel and PowerPoint required. Proficiency with Microsoft Access and Project desirable
- Effective research and analytical skills
- Effective written and oral communication, technical writing and editing skills
- Ability to work independently with minimal supervision
QUALITY SYSTEM REQUIREMENTS:
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
BOSTON SCIENTIFIC (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit us at www.bostonscientific.com.
Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-CA-Fremont||(n/a)||Regulatory Affairs||(n/a)
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland
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