CyberCoders Senior Regulatory Affairs Specialist in Lancaster, New York
Senior Regulatory Affairs Specialist Senior Regulatory Affairs Specialist - Skills Required - ISO 13485, Regulatory Affairs, FDA
If you are a Senior Regulatory Affairs Specialist with experience, please read on! The Senior Regulatory Affairs Specialist will support new product development for OEM products in both a quality and regulatory capacity to ensure products meet customer requirements and maintain state of the art. This person will be responsible to interface directly with customers to provide a high level of quality and regulatory support that meets or exceeds customer expectations.
What You Will Be Doing
-Perform duties required for supporting OEM customers including: audit hosting, contract review, new product development support, resolving complaint issues with customers and regulatory authorities, assuming responsibility for regulatory compliance for OEM medical devices sold to the European Union and product registration support for other countries
-Review and comply with all applicable quality system regulations and company policies and procedures
-Perform Clinical Evaluations and prepare Clinical Evaluation Reports according to current standards and requirements for OEM products
-Investigate and document customer complaints using 8D problem solving tools as appropriate
-Compile periodic reports for review of customer complaints and use the data to revise the product risk documentation
-Prepare and submit change requests to OEM customers for product and process changes as required by the customer
-Participate on new product development teams for OEM products. Provide Quality and Regulatory support including: preparing Technical File documentation, US 510(k) documentation, and validation reports as needed
-For any assigned CAPAs, coordinate containment and correction activities, perform root cause investigation, develop corrective action plan and evaluate effectiveness
-Assist OEM customers with product registration requirements in Canada by completing private label licence applications
-Perform and document Internal Audits as assigned
-Participate in external audits from customers and Regulatory Bodies
-Review labeling requirements for OEM products registering them in the FDA GUDID database
-Recommend improvements to the quality system based on review of new regulations to maintain compliance to state of the art requirements
-Participate on the Environmental Team to support the EMS
What You Need for this Position
-BS in biomedical engineering or related field
-10+ years of quality and/or regulatory experience in FDA regulated industry
-ISO 13485 Experience (Preferred not required)
-Ability to read and interpret engineering drawings, regulations, and other technical documents
-Knowledge of medical device manufacturing processes and requirements
-Team leadership and/or supervisory skills to work closely within department
-Excellent communication, organizational and multi-tasking skills
Top Reasons to Work with Us
We're a world leading medical device manufacturer and supplier of surgical smoke evacuation equipment!
What's In It for You
-Awesome Benefits Package
-401(k) employer match plans
So, if you are a Senior Regulatory Affairs Specialist with experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Senior Regulatory Affairs Specialist NY-Lancaster LD4-1465172