FierceHealthcare Jobs
Regulatory Affairs Compliance – MED#206 - Executive Office Services
Jul 13
Location: New Jersey, NJCategories: Administrative
Position Description
EXECUTIVE OFFICE SERVICES
Human Resources Consultants
POSITION: Regulatory Affairs Compliance – MED#206
EMPLOYER:
Executive Office Services is privileged to partner with a Medical Device Company that is seeking your assistance in identifying an exceptional Regulatory Affairs Compliance Manager.
LOCATION: New Jersey – No Relocations Assistance – Local Candidates Only!!
QUALIFICATIONS:
Although, Individual are encouraged to apply, however, the Ideal candidate with the following experience will only be considered. Bachelor’s degree in the Engineering or Scientific area; Master’s degree preferred. 10 to 15 years experience in the Medical Device Industry, with direct experience in Regulatory Affairs and Quality Assurance. Demonstrated thorough knowledge of FDA regulations, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), Canada Medical Device Law and other National and International regulations and standards.
CAREER OPPORTUNITY:
Provide Regulatory Affairs review and approval of validation protocols and completion reports, Engineering Change Orders, nonconformance reports and other documents as necessary. Serve as Deputy Management Representative for compliance with ISO 9001, ISO 13485, CMDR, and the Medical Devices Directive. Work with Corporate Regulatory Affairs department to assure complete and timely completion of annual reports for PMA products manufactured at the Plainsboro facility. Demonstrate documentation experience in Validations, engineering documentation, 510k decision trees, and Pre-Market Approval (PMA) impact assessments. Plan, prepare and review domestic and international regulatory submissions for products manufactured at the facility. Serve as the Regulatory representative for project teams and determine regulatory strategies for assigned projects. Review product and process changes for impact on existing regulatory approvals, clearances, and notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures. Participate, in conjunction with Quality Assurance, in FDA inspections, ISO audits and customer audits at the facility. Participate on new product development project teams as site Regulatory Affairs representative. Manage the change control program. Manage the program for review and approval of vendor supplied and in-house printed labeling for product manufactured at the facility. Oversee review and approval of in-house computer generated product labels. Manage the Plants internal Audit program. Manage the Documentation Control System for the Manufacturing plant. Perform internal and supplier audits as necessary. Manage and Control the Manufacturing Plant label approval and review process. Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary. Perform other related duties as required.
SALARY: Up to $120K – Based on Experience
Thank you for taking the time to share this information with your business colleagues. Any inquiries will be held in the strictest confidence. I look forward to hearing from you soon
Please send resumes in Word Document Format or Email a Word Attachment Only. No PDF Files Please
Send resumes email to:
Executive Office Services. CAREERS@EXESERVICE.BIZ
Phone: (510) 830-9721
Executive Office Services is an Executive Recruiting Consultant Enterprise dedicated to helping professionals in furthering their career goals. Success is attributed to the personalized service, with the goal of bringing together qualified business professional with quality companies. We have a variety of opportunities available. Feel free to pass this information along to your network of business colleagues, and if you are looking or know of business professional within your network that is looking for an Executive Human Resources Consultant please feel free to send your resume.
Executive Office Services. CAREERS@EXESERVICE.BIZ
Phone: (510) 830-9721
Due to the high volume of resumes received daily from candidates responding to positions nationwide, you may not be contacted immediately. If you are not contacted within 7 business days, we may not have a position meeting your expertise or the position you applied for has been staffed. Should that be the case, we will place your resume in our keyword searchable database. In the event an opportunity becomes available which requires a professional with your expertise, a representative will contact you, regarding your availability and interest in the position.
