Principal Regulatory Affairs Specialist
Job Requisition #: 11284
Date Posted: 06/27/2011
Category: Regulatory Affairs
Location: Plymouth - MN - USA
About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Cardiovascular Division:
Job Overview
As a Principal Regulatory Affairs Specialist you will support, develop, and follow SJM CVD and Amplatzer product procedures, compliance programs and ethical guidelines/requirements; evaluate the regulatory environment and provide internal advice throughout the lifecycle of the product (e.g., concept, development, manufacturing, marketing) to ensure product compliance; and provide regulatory intelligence to develop local and regional regulatory strategies.
Responsibilities:
• Participate in initiatives to identify regulatory requirements and develop submission processes for new AGA markets.
• Identify, monitor, and submit applicable amendments or notifications to regulatory authorities to comply with regulations.
• Ensure regulatory compliance of labeling.
• Evaluate proposed manufacturing changes on pre-clinical and clinical development and regulatory submission strategies.
• Comply with product post-marketing surveillance requirements to meet conditions of approval.
• Participate in crisis/issue management team (e.g., product recall, counterfeiting) and assess the regulatory impact of an event and proposed resolution.
• Maintain product licenses and submit renewals as required.
• Provide required information in support of product reimbursement or tenders.
• Participate in and/or lead process improvement initiatives to streamline regulatory submission preparation processes for assigned markets.
• Maintain records on legislation, regulations, guidelines, standards, and related issues for background purposes to facilitate compliance.
• Assist other departments to develop SOPs to ensure regulatory compliance.
Basic Qualifications:
• Bachelors degree in business, engineering or sciences
• 8+ years industry experience in medical device regulatory affairs
• 4+ years of regulatory affairs experience with Class III medical devices
• Knowledgeable and able to interpret and operate using federal and other regulations (e.g., Quality System Regulation, Code of Federal Regulations, Medical Device Directive)
• Excellent organizational, interpersonal and communication (verbal and written) skills
• Computer proficiency in MS Word, Excel, and Outlook
• Ability to interact with a range of personalities and many levels of the organization
Preferred Qualifications:
• Masters degree in business, engineering or sciences
• International regulatory affairs experience with Class III medical devices
|E-mail this position
Submit Resume or C.V.
