-SUMMARY OF DUTIES--Responsibr coordinating, preparing, and maintaining regulatory submissions and documents on a global levr Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory complianr assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect Merit's business and products, assisting wcility inspections, Notified Body audits, and other internal audits. Performs duties with limited inpom management and/or senior members of the department.-ESSENTINCTIONS PERFORMED-- Determines global regulatory pathwar various projects including product classification and type of regulatory submission or rationale required. Participates on various teams to define regulatory requirements of U.S. and international submissions, Technicles or regulatory rationales. Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation. Prepares regulatory submissions to tA, the Notified Body and other regulatory authorities. Prepares IDEs and PMAs and assists with clinical trials when required. Interacts with various levels of management, rnal agencies and companies. Analyzes and makes recommendations regardield complaints. Develops, maintains and analyzes department systems and provides Confidencial when needed. Remains current on developing regulations and revises systems as necessary. Participates in and assists wcility inspections, Notified Body Audits and other inspections and audits as directed. Assists with supervisión of department staff, as directed. Performs other related duties and tasks, as required.-ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS-- Lifting Not to exceed lbs local practice may apply. Writing Sitting Standing Bending Visual acuity Color perception Depth perception Readield of vision/peripheral--SUMMARY OF MINIMUM QUALIFICATIONS-- Education and/or Importante empresa equivalent to a Bachelor's Degree in a techniceld such as the biological, physical, engineering or material science disciplines and six years of related industry Importanteempresa. Demonstrated knowledge of U.A regulations, the Medical Devices Directive (9//EEC, as amended), and various System Standards/Regulations/Laws, including but not limited to ISO 3485, etc. Demonstrated and verifiable Importante empresa with authoring regulatory submissions and interacting with reviewers.Self-motivated, self-directing, strong attention to detail and excellent time management skills. Strong interpersonal skills and the ability to communicate well verbally and in writing with others. Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.-COMPETENCIES-- Regulatory submission/rationale preparation Global Regulatory paths/strategies Computer skills/internet research Interpersonal/communication skills Regulatory system development/trainield Action coordination and reporting Product development and change qualification processes--COMMENTS--Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or bouids while performing their jobs. Risk category III states employment and procedures that do not require exposure.-Requirements--:
At Confidencial, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.As an eligible Merit employee, you can expect tllowing:
- Multiple Shifts and Hours-- to chooom--:
Days, Swing (Eve), and Nights--:
- Medical/Dental & Other Insurances-- (eligible trst of month after days) No Cost --Onsite Dental Clinic-- | Low Cost --Onsite Medical Clinic--:
Two () --Onsite Cafeterias--:
- Employee Garden-- | Gardening Classes -- Weeks' Vacation | Week Sick-Time | Paid Holidays--:
- 401K | Health Savings Account----Follow Us--:
- Day in the Life--: