GENERAL SUMMARY
Reporting to the Sr. Regulatory Affairs Manager, this position will strategically and tactically organize the review of regulatory documentation (510(k), IDE, PMA, periodic reports) for submission to the FDA, and foreign regulatory bodies in support of market clearance or product licensure. A focus of this position will require working knowledge in the filings, assist in the strategic design and preparation of responses to inquiries from regulatory agencies, and will provide support for the company's regulatory systems. In addition, the position will represent regulatory affairs on new product development and sustaining engineering project teams.
• Draft, review, assemble, and publish device/drug applications in accordance with FDA and foreign regulatory body requirements;
• Work with support groups to resolve significant issues, which may impact the submission;
• Serve as a Regulatory expert on new product development and sustaining engineering project teams.
• Actively participate in the formulation and administration of company regulatory policies and in the development of departmental goals and tactics;
• Serve as a Regulatory Lead resource to other departments, providing regulatory and technical review of documentation, and writing departmental SOP's.
• Review and approve marketing promotions and advertising based on FDA and/or regional international labeling requirements; • Review and approve product labeling and advise on content as required.
• Lead assigned Regulatory Affairs initiatives aimed at improving internal company standards and systems.
• Work effectively with global functions across the business, particularly risk management, safety and engineering.
• Work with global regulatory staff to ensure USA and regional regulatory requirements are met. Global initiatives and assignments will be conducted under the direction of the Sr. Regulatory Affairs Manager.
• Provide technical support as the Documentum for Global dossier submissions.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects as needed..
Required Skills
QUALIFICATION REQUIREMENTS
• Working knowledge of FDA, EU, international regulatory requirements.
Knowledge of electro-mechanical device registration.
•A flexible attitude with respect to work assignments, new learning and travel; .
•Ability to work professionally with highly confidential information;
•Experience with Microsoft based applications and general knowledge of PC functions;
•General knowledge of electronic submission requirements and associated software programs.
•Working knowledge of electronic submission preferred (Documentum);
•Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail;
•Must possess considerable initiative and be willing to work with multiple disciplines in a fast-
•moving environment, and to value the importance of teamwork;
•.Must posses excellent interpersonal, organizational, and written communication skills including ability to assume a leadership role;
•Strong verbal, organizational, and analytical skills and computer literacy required.
COMPUTER SKILLS:
Fluent in Microsoft Word, Excel, and working knowledge of internet (Microsoft explorer) functions. Electronic submission software [Documentum] experience preferred.
Required Experience
EDUCATION AND/OR EXPERIENCE:
Bachelor's degree in scientific discipline required. 2-3 year minimum experience within Regulatory Affairs in medical devices--Experience in technical writing, and display knowledge of FDA and International regulations/requirements as they pertain to device submissions.
PHYSICAL DEMANDS: This position is Stationary in nature, generally requiring 80% sitting and 20% walking/standing and requires manual dexterity to operate computer, telephone, etc. Domestic and International travel is required (e.g., 20%).
Position Type
Full-Time/Regular
