We are seeking for a Manager Regulatory Affairs Job Description: DEPARTMENT: Quality Assurance / Regulatory Affairs DATE EFFECTIVE: October 1st, 2013 DATE REVISED: N/A POSITION TITLE: Manager Regulatory Affairs POSITION REPORTS TO: Director Quality Assurance / Regulatory Affairs POSITION SUPERVISES: Design Assurance Engineers; Regulatory Affairs Specialists BASIC PURPOSE: Ensure regulatory compliance for medical and non-medical devices and software. Interface to regulatory authorities for device registration ESSENTIAL DUTIES AND RESPONSIBILITIES: 1. Determines and communicate submission and approval requirements. 2. Managerial responsibility and Leadership for the Regulatory Affairs Group (3 -5 employees / Professionals / Specialists) 3. Deputy of Director Quality Assurance / Regulatory Affairs 4. Implements and maintains an ERT wide medical device regulatory strategy. Provide this regulatory strategy to all stakeholders in development projects and change projects. 5. Compile, Review, Improve and maintain ERT wide Regulatory Affairs procedures 6. Perform international internal and vendor audits to assure compliance with international medical device regulations. 7. Provides ongoing support to other departments for regulatory issues and questions. 8. Prepares and compiles submission strategies in case of new products or changes. 9. Compiles, prepares, reviews and submits regulatory submission to authorities, this includes but is not limited to the following: 510(k), CE, CMDR, PAL, SFDA. Contacts to national authorities in different countries. 10. Assures compliance with product post marketing approval requirements as medical safety officer. Contact to different national authorities in case of a recall. 11. Ensures compliance with design controls and reviews design documentation to insure regulatory requirements are met. 12. Monitors and evaluates the impact of regulation changes for existing products as well as submission strategies for new registrations and re-registrations. 13. Submits and reviews change orders to determine the level of change and consequent submission requirements. OTHER DUTIES AND RESPONSIBILITIES: 1. Provides regulatory support to currently marketed products as necessary. 2. Updates and maintains Technical Files for medical devices 3. Implements, maintains and improves Regulatory Affairs Standard Operating Procedures and Standard Work Instructions. 4. Assures continued compliance by identifying and correcting gaps in procedures and designing and presenting training programs to educate associates at all levels within the organization. 5. Supports Product Development teams on existing and new product development, based on market needs, to input into the development process, document and implement regulatory strategies, including registration requirements, documentation needed to help facilitate timely launch of new products. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract. QUALIFICATIONS AND SKILLS NEEDED: 1. Bachelor’s Degree (BS or BA) in technical discipline, preferably in a life science / medical device field, or equivalent combination of education and experience in domestic / international submissions and / or regulatory compliance. 2. At least 3 years working experience in regulatory affairs for a medical device or life science company. 3. Knowledge of 21CFR Part 11, 21 CFR 820, ISO 9001/13485, Canadian and Japanese Medical Device Regulations and/or other applicable regulatory standards especially ISO 14971, ISO 62304, ISO 62366 4. Previous domestic / international submissions experience (510(k), CE – mark, etc.) 5. Leadership experience and employee management in Regulatory Affairs department is preferred. 6. Fundamental knowledge of the regulatory directives and laws in key global markets. 7. German and English Fluent (third language preferred) 8. Willingness to travel internationally (
Posted on: Thu, 26 Sep 2013 07:24:11 +0000
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