Regulatory Affairs Specialist

GENERAL SUMMARY: The Regulatory Affairs Specialist will act as regulatory representative on cross functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work closely with each project team to develop regulatory strategies, testing requirements and other documentations to assure that regulatory submissions are prepared and cleared/approved to meet the company’s product launch timelines for new and modified products. ESSENTIAL FUNCTIONS: Work closely with each New Product Development team in developing the regulatory strategy for the new and modified products. Work closely with the product managers to understand the country’s registration needs and priorities and provide regulatory input to the product managers such as registration strategies, timeline, and costs. Work closely with engineering team on the testing requirements and support the development of verification and validation testing plan. Review engineering documentation under the design history file to ensure compliance with the standards, guidance, and regulatory requirements. Prepare regulatory submissions such as 510(k), Letter to File, Health Canada Submission, Technical Files, etc. for new and modified devices. Updates and maintains databases with required information and status for UDI, GUDID, licenses, approvals, renewals, and other required data to assure compliance with business and regulatory requirements. Review and approve product, supplier, and manufacturing changes for compliance with applicable regulations and applicable procedures. Work closely with Regulatory and Clinical Affairs team members to provide regulatory change assessments for each country/region where the products are registered. Work closely with Regulatory and Clinical Affairs team members in monitoring the impact of changing regulations of each country on submission requirements and strategies. Assign, review, revise and approve device labeling and marketing materials to ensure continued compliance with global regulations. Provide support in developing regulatory procedures when necessary. Provide regulatory input for product recalls and recall communications. Performs other duties as assigned. SUPERVISORY RESPONSIBILITIES: There are no direct supervisory responsibilities for this position. QUALIFICATIONS: Demonstrate a fundamental understanding of medical device terminology, anatomy, regulations, standards and technical concepts Understanding of regulations and guidelines governing all phases of Medical Device development with guidance and supervision. Understanding new product development requirements and processes with guidance and supervision. Excellent technical writing and editing skills, verbal and written communication skills including presentation skills. Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities. Able to work within deadlines as imposed by government regulations and internal guidelines. Able to take direction and work and solve problems both independently and as part of a team. EDUCATION AND/OR EXPERIENCE: Requires a bachelor’s degree; advanced degree preferred. Minimum of 2 years’ experience in regulatory of medical devices is preferred. LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling. MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent. REASONING ABILITY: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver’s license. OTHER SKILLS AND ABILITIES: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation will be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is that found in a normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel. The above statement reflects the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation. #J-18808-Ljbffr