Manager Of Regulatory Affairs Jobs in Indiana

Job Title: Regulatory Affairs Manager - Direct Hire Opportunity Company: Kelly Scientific Resources Location: Warsaw, IN Description: Regulatory Affairs Manager - Direct Hire Opportunity Kelly Clinical Research has a Direct Hire Regulatory Affairs Manager Opportunity available in Northern IN!  Overall Responsibilities: Supports President, Company Sports Medicine and is Responsible for managing regulatory affairs, regulatory compliance, and quality Assurance pursuant to federal, international and corporate regulatory requirements and standards.  RESPONSIBILIITES: Will manage complaints ensuring that complaints are successfully investigated and closed within the required 90-day time frame. Will manage complaint personnel, signs complaints, performs trend analysis, and presents at monthly CAPA meetings. Will investigate and author Health Hazard Evaluations HHE and arranges and conducts the HHE meetings. Will coordinate on recall notices as necessary. Will manage internal audits ensuring that the audits are completed as scheduled. Will manage design history reviews and performs regulatory audits of completed design files. Will manage domestic and international submissions ensuring the completion of 510k s or other submissions/documentation required by the US FDA and international submission in designated countries. Will manage regulatory affairs and compliance personnel including expenses/budgets and approves and establishes quarterly objectives. Will manage quality assurance engineering including COGS expense and provides input on quarterly objectives. Will perform and provide guidance and/or assist in defining, implementing and follow-up of systematic corrective and preventive actions CAPA and approves all BSM related CAPAs. Will provide support for 3rd party audits FDA, Notified Body within the BSM SBU. Will provide regulatory support in the areas of quality planning and special process validation through protocol development, execution and summary reports. Functions as management representative for BSM and presents BSM data at the management review meetings. Miscellaneous duties as may be required by the needs of the business. Requirements: REQUIREMENTS: Minimum of a Bachelors degree 10 years of practical medical device manufacturing experience preferred. A working knowledge of FDA and regulations and how to interpret and monitor them with experience or knowledge in Quality Systems relating to 21 QSR Part 820 and ISO 13485:2003. Knowledge of CAPA, Quality Planning, Process Validation and Quality Auditing. Computer skills required, including Microsoft Excel, PowerPoint and Word. AS/400 experience is a plus. Domestic and international travel may be required. If you meet the above qualifications and would like to be considered for this opportunity, please click on Apply Now! Or you may refer a friend by clicking 'Email this opportunity to a friend'. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer.

Job Title: Regulatory Affairs Manager (15731) Company: ITT Tech Location: Carmel, IN Description: 15731 Job Description The Opportunity At ITT Educational Services, Inc., we are committed to helping men and women develop the skills and knowledge to pursue many career-changing opportunities. The Regulatory Affairs Manager position is responsible for securing state and accrediting agency approvals for new colleges and programs. This collaborative leader will serve as advisor/consultant to existing college management teams as they prepare for and respond to accrediting agency team visits. Key Responsibilities Responsible for researching and reviewing actual and proposed changes in state and federal statutes and regulations. Presents oral testimony in public hearings as required. Reviews catalogs, enrollment agreements and advertising copy for compliance with state and accreditation requirements. Meets with state administrators to introduce ITT Technical Institutes and responds to state board inquiries in order to prevent delays in licensing. Attends accreditation visits to colleges to insure information is provided to the accreditation team to prevent report write-ups. Required Skills A Bachelor degree in Business, Liberal Arts or Social Sciences or related field from an institution accredited by an accrediting agency recognized by the US Department of Education is required. Legal education or experience is a plus. Minimum two (2) years progressively responsible experience in regulatory or compliance related position. Excellent written and verbal communication skills. Proficiency in Microsoft Office products including Word, Excel and PowerPoint. Proven experience working in a collaborative team environment. Ability to represent the Company to all levels of management and senior level government officials. Ability to travel by plane at least 10% of the time. Job Location Carmel, IN, US. Position Type Full-Time/Regular