Director Of Regulatory Affairs Jobs in Ohio

Job Title: Senior Manager, Regulatory Affairs Company: STERIS Corporation Location: Mentor, OH Description: Employer Information About STERIS Corporation STEIRS Corporation is a leading global manufacturer and supplier of infection prevention, contamination control, decontamination, microbial reduction, and surgical and critical care support products, technologies and services used in the military, government, emergency response, healthcare, pharmaceutical industries and laboratory research facilities around the world to safely and effectively prevent contamination and combat infectious diseases. View all our jobs Job Join STERIS in its vision to see the world free from infection and contamination as a Senior Manager, Regulatory Affairs Summary The mission of the Regulatory Affairs Submissions and Registrations function is to implement efficient and effective processes to initially obtain and then maintain registration approvals to market STERIS products in designated countries in support of STERIS’s global business plans. This includes determining registration and/submission requirements in the various markets, identifying the documentation needed to meet the identified requirements, and working closely with STERIS corporate domestic and international staff, STERIS distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents, while using electronic record-keeping tools according to departmental policy. This group identifies and supports Regulatory Compliance needs in all markets. Essential Job Duties Identify and keep current with the various international country submission/registration/approval and compliance requirements for marketing STERIS products domestically and in 50+ countries outside the U.S.A. where STERIS does business. Participate and represent Regulatory Affairs on the cross functional New Product Development Teams. Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified. Gather information and documentation on new or modified products to determine submission requirements for particular markets. Compile and create document packages (dossiers, 510(k)s, Technical Files, Minor Modification files) through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities. Critically assess the strength and completeness of documentation created by others; advise improvements to comply with current requirements for particular regulatory authorities. See that all staff members maintain paper and electronic submission documents, databases, and other regulatory records in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. Review and approve product labeling, including marketing/promotional/technical literature to ensure that all label formats, product claims and instructions for use are appropriate and consistent with cleared indications for use, product design documentation, and US and international regulations/standards as applicable. Manage the selection and use of software tools for registrations tracking and reporting, including training and support of Regulatory Affairs staff in use of IRST, Sharepoint sites, and other tools; work with IT and Customer Operations on system improvements and de-bugging. May be asked to install, configure, update, serve as administrator, and train Regulatory Affairs staff in the use of software tools to organize and manage the registration process. May be asked to serve as administrator for validation software tool – set up user access, certify that users are trained in computer system validation and use of the tool; set up new validation projects in the system, field technical questions from users. In the role of Regulatory Representative, apply regulatory knowledge and judgment to the evaluation of product modifications, communicate potential regulatory compliance issues, and assist the facility in addressing regulatory issues in a timely manner. Responsibilities include: Gathering core information from manufacturing, quality, etc. to assess the significance of a proposed product change and, when applicable, forwarding the information to Regulatory Affairs management for review; Providing technical guidance to the Quality Team establishing validation test plans and protocols and to comply with industry standards and FDA guidance documents; and Participating in cGMP compliance audits initiated by FDA, International 6 Governmental agencies, Notified Body BSI and customer inspections. Set goals, guide project activities, track progress, report status as appropriate, and take action on unexpected setbacks to avoid delays, late filings, or disruption in product availability. Working Conditions/Physical Requirements General office working conditions. Position may require approximately 20% local or international travel to STERIS facilities, government agencies, customers, trade shows or training courses. Supervisory Responsibilities The Regulatory Affairs Manager has staff management responsibilities and/or project management responsibilities. He/she will lead teams including other regulatory staff and staff from other disciplines in achieving the objectives of the assigned projects. The RA Manager will also assist with training of regulatory staff in subject areas where he/she has expertise. Nature of Problem Solving Ability to work in a highly complex environment under general direction as to assignment and occasional review. Considerable problem solving is required, including the resolution of technical questions through identification and interpretation of scientific documentation. Ability to resolve conflicts between differing priorities of various process stakeholders by formulating pragmatic solutions and obtaining consensus. Empowerment and Decision Making Environment Access to all company confidential product and business information to perform the duties of the position. Evaluates the effectiveness of policies, procedures and systems impacting the global registration of STERIS products and services, and recommends improvements to Regulatory Affairs management. Operates independently under Director’s guidance. Resolves problems of moderate to high complexity, including high impact decisions. Initiates action to achieve project goals and avoid non-compliance. Interacts daily with STERIS employees, customers and government officials from different cultures and must possess a strong cultural awareness and sensitivity. NOTES: Local Country Candidates Only. Employer will assist with relocation costs

Job Title: Vice President, Quality & Regulatory Affairs Management... Company: Cardinal Health Location: Dublin, OH Description: Title: Vice President, Quality & Regulatory Affairs Management - PET Location: Ohio-Dublin - Cardinal Place WestJOB TITLE: VP, Quality & Regulatory Affairs Management - PET At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Function: QRA Family: QRA ManagementWhat QRA Management contributes to Cardinal Health QRA Management is responsible for strategic oversight and leadership direction within the QRA functionWhat is expected of you and others at this level in Quality & Regulatory Affairs for functional success * Provides leadership and direction for multiple functional areas through Directors (M3); may also manage Managers (M2) * Deploys resources to achieve financial and business objectives * Shapes and integrates functional strategies * Has in-depth functional and business expertise * Applies business expertise to develop financial and operational objectives * Makes decisions, often difficult and/or unpopular, that support and drive the organization strategy; influences others to support the decisions. Fosters personal courage in others * Role models Cardinal Health's high ethical standards and code of conduct * Provides resources for developing skills/capabilities and creates unique development opportunities; serves as a resource and support for development efforts * Develops plans for managing talent inside and outside the organization and for improving leadership bench strength; drives the succession planning process * Sets aggressive function or cross-functional goals that support organizational goals * Ensures plans are in place to meet/exceed goals while providing motivation and inspiration * Ensures results are achieved by providing resources, removing obstacles and helping others envision the end result * Manages and deploys resources, leveraging knowledge of competitive advantage and profit drivers * Identifies internal/external business issues that may impact organizational results * Creates and sets strategy based on anticipated internal/external trends * Leverages relationships with key internal/external customers to support business needs and challenges * Creates innovative solutions that take into account a variety of business needs and shares key learnings with others * Directs the resolution of highly complex or unusual business problems * Creates systems and processes that enable and require people to challenge "traditional ways" and invent/apply "new ways", constantly emphasizing and demonstrating operational excellence and balanced risk taking * Creates relationships across the company and with external parties to reach consensus on complex strategic issues, leveraging cultural and individual differences among parties to maximize success; champions team decisions * Negotiates with customer and/or organizational leadership through effective listening and communication to set priorities Accountabilities in this role * Leads a systematic approach to improve the quality and compliance record of the PET manufacturing sites. * Ensures adherence of all PET manufacturing sites to regulatory expectations and regulations relevant to PET drug manufacturing (eg. 21CFR part 212). * Works with operations to enhance process reliability and robustness across the PET manufacturing network resulting in improved quality/compliance, product reliability and financial performance. * Establishes and ensures alignment of quality and compliance metrics all PET manufacturing sites. * Coaches PET QRA leadership team to ensure continuous improvement through the optimal applications of technological and process solutions. * Identifies and facilitates the adoption of best practices across all the manufacturing sites.  * Ensure adequate resources are available to comply with all regulatory requirements and expectations * Serves as a Subject Matter Expert to address complex manufacturing investigations or challenges * Serves as the company lead during FDA inspections. Also, interacts with the agency to address inquiries and for issue resolution. Qualifications * Bachelor's degree required, advanced degree preferred * 6 years of management experience strongly recommended * Excellent leadership and communications skills *  10 to 15 years of relevant experience in pharmaceutical drug product manufacturing with at least 7 years experience managing quality groups (QA, QC, Compliance, or Quality Systems) . *  At least 3 years experience working with aseptic manufacturing processes *  Experience in other functional areas such as Operations, Technology Services and/or R&D are highly desirable. *  Experience leading FDA inspections.Please refer to job code dinalhealth-10000616 when responding to this ad.

Job Title: Regulatory Affairs Manager (214653-072) Company: Invacare Location: Elyria, OH Description: 214653-072 Job Description Manage adverse event complaint handling process.  Manage Corporate Complaint handling system for all North American Invacare facilities in conformance with FDA and Health Canada requirements.  Ensure that all potential sources of complaints are reviewed and documented per these requirements. Ensure that adverse event complaint information is reviewed on a timely basis for information which may require reporting to FDA under the MDR Reporting Regulation.  Determine if MDR reports are required and submit reports when necessary. Ensure that decisions not to file such reports are justified and documented. Manage investigation and follow-up activity of safety related product issues where injury or the potential for injury has been identified. Ensure appropriate documentation is included in the complaint files.  Review complaint responses for adequacy and close out complaint files accordingly. Track progress of recalls and submit monthly updates as required to meet FDA requirements. Participate in Safety Committee meetings and provide updates regarding complaint / MDR activity and recall status. Perform trend analysis and ensure complaint information is communicated regularly to all Invacare personnel who need this information.  Submit 510(k) applications to FDA when requested by supervisor and participate in the engineering change control process to provide guidance regarding engineering changes and potential 510(k) or other regulatory impact. Required Skills Four (4) year Technical Degree or equivalent experience. Knowledge and understanding of QSR’s and ISO Quality System Requirements.  RAC Certification desirable Minimum 5 years Quality Assurance or Regulatory experience in a Manufacturing Discipline. Thorough knowledge of trend analysis reporting techniques and methods. Previous experience in product failure analysis desirable. 3 - years experience with Medical Device Reporting Experience with FDA 510(k) submissions and Part 806 requirements Excellent oral and written communication skills. Some supervisory experience is required. Ability/willingness to travel. Job Location Elyria, OH, US. Position Type Full-Time/Regular

Job Title: MGR REG AFFAIRS Company: Abbott Nutrition Products Division Location: Columbus, OH Description: Primary Function/Primary Goals/Objectives:- Assist in definition/implementation regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.- Applies established policies and best practice regulatory standards within regulatory and affiliates for agency filings and interactions.- Under management direction, assures consistent reviews of labels and promotional items across product lines, establishes procedures to assure regulatory compliance, and negotiates regulatory positions on issues.Major Responsibilities:1. Effectively communicates regulatory requirements to affiliates, colleagues, and partners, influencing/negotiating as needed to ensure regulatory requirements are met. Assists in definition/implementation of regulatory strategies and priorities for assigned products.2. Ensures needed data for regulatory purposes are identified, obtained and effectively presented. Assesses programs and attends meetings, providing strategic input and negotiating with affiliates, colleagues, and partners to ensure regulatory data requirements are met to support promotional efforts.3. Represents ANRA regulatory on departmental and divisional teams, providing timely regulatory input to ensure regulatory requirements are met.4. Interfaces, under management direction, with regulatory agencies and affiliates to address agency and affiliate inquiries and actions.5. Coordinates, prepares and reviews regulatory submissions to assure effective data presentations, complete and timely responses to affiliates and regulatory agencies, and quality levels consistent with regulatory requirements and guidance.6. Assures established policies and standard interpretations of regulations are followed for assigned projects. Develops new/revised policies and standard interpretations of regulations across the Area under management direction. Maintains an awareness of legislation and assesses impact on Abbott business.Specific Responsibilities:1. Position will be responsible for infant formula products, including coordinating collection of regulatory submissions, in the US and Canada.2. Position will be responsible for review of labels, labeling, and promotional materials for US and Canada. REQUIREMENTS - QUALIFICATIONS: MGR REG AFFAIRS Basic Qualifications:1. Prior regulatory experience in the food, dietary supplement or pharmaceutical industry is strongly preferred but not required.2. Knowledge of US and/or Canadian regulations relating to foods or infant formula3. A Registered Dietitian is desirable but not required.4. Ability to work constructively, decisively, and collegially with regulatory agencies and internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.Preferred Qualifications: A Bachelor’s degree in nutrition, chemical or biological science is required; a Master’s degree is highly preferred.Abbott Nutrition Products Division