Principal, Regulatory Affairs Specialist
Responsible for preparing US and international regulatory submission and registration activities. Maintains facility registrations, device listings, and regulatory licenses. Prepares design dossiers, technical files, registration/approval documents for USFDA and other international markets. Maintain and file regulatory correspondence and other submissions. Communicates with regulatory agencies. Under direction participate in new product development core teams and create regulatory strategies. Be willing and able to perform other responsibilities as assigned. Experience in medical device regulatory function is a must.
- Develops documents for a regulatory submissions to US FDA, EU notified body and other regulatory agencies
- Maintains European and international technical files/dossiers/registrations as required
- Participates in new product development teams and provide regulatory support consistent with regulatory strategies
- Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status
- Prepares for and maintains facility registration, device listing, periodic reports etc. per U.S. FDA requirements and the requirements of foreign markets
- Maintain a list/database of product approvals/registrations
- Assembles Common Technical Document (CTD) and electronic CTD filings for USFDA and other international regulatory agencies
- Ensures continuous update and maintenance of the Regulatory Affairs documentation
- Coordinates company activities to ensure the timely submission and approval of applications, amendments, supplements, and other regulatory correspondence
- Interprets, executes and recommends modification to internal guidelines, work instructions, and procedures related to regulatory affairs
- Monitors industry and regulatory trends and develop strategy and provide guidance related to such trends
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel
- Leads and interacts with appropriate departments to obtain required information for regulatory submissions and correspondence
- Tracks the status of regulatory submissions during submission development and review/approval progress and communicates to management
- Corresponds with cross-functional individuals, and external agencies as assigned
- Assists on other projects and tasks as assigned
- Analytical – Be able to identify missing information, evaluate accuracy of the presented information
- Design – Demonstrates strong attention to detail.
- Oral Communication – Listens and gets clarification; responds well to questions; understands nuances related to regulatory matters. Communicate with all levels.
- Written Communication – High attention to detail and error-free work. Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. Capability of significant level written communication with external agencies, international distributors, and internal individuals is a must.
- Organizational Support – Follows policies and procedures; supports organization’s goals and values.
- Adaptability – Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
- Dependability – Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time. Keeps and follows up on commitments.
- Motivation – Demonstrates persistence and overcomes obstacles
- Planning/Organizing – Prioritizes and plans work activities; uses time efficiently; develops realistic action plans. Maintains document files in an organized fashion.
- Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
- Bachelor’s degree in life science or engineering
- Minimum 7 years of medical device regulatory affairs experience with USFDA and international regulations and submissions. Fewer years of experience may be considered for the candidates with Master’s degree in engineering.
- Ability to work independently and as part of a team
- Demonstrated ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals
- Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems
- Excellent verbal and written communication skills and the ability to work with all levels within the Company, international distributors, and regulatory agencies
- Strong organizational skills and attention to detail
- Experience with sterile disposable device submissions and submissions including software is required
EQUAL OPPORTUNITY EMPLOYER – DISABILITY AND VETERAN
Learn more here
Job posted: 2021-03-16