What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Getinge?
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Location: 40 Continental Blvd., Merrimack, NH 03054. Employer will allow remote/telecommuting throughout the U.S.
Job Duties: Collects information and documentation for routine submissions to regulatory agencies. Seeks out related documentation as required to request agency approvals or in response to agency requests. Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency. Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirements. Gathers regulatory submissions to be reviewed for compliance and submission standards. Tracks through review process to ensure timely submission. Support with Field Correction and Recall activities. Participates in the review and disposition of labeling, promotional material and product modifications. Prepares documentation and coordinates activities related to EuMDR, PMA's, 510(k)'s, and IDE's. Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations. Assists in special projects as needed.
Requirements
Bachelor's degree in a scientific or engineering discipline plus 2 years of experience with regulatory affairs or related. Requires skills and experience in the following:
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits At Getinge
At Getinge, we offer a comprehensive benefits package, which includes:
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Location: 40 Continental Blvd., Merrimack, NH 03054. Employer will allow remote/telecommuting throughout the U.S.
Job Duties: Collects information and documentation for routine submissions to regulatory agencies. Seeks out related documentation as required to request agency approvals or in response to agency requests. Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency. Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirements. Gathers regulatory submissions to be reviewed for compliance and submission standards. Tracks through review process to ensure timely submission. Support with Field Correction and Recall activities. Participates in the review and disposition of labeling, promotional material and product modifications. Prepares documentation and coordinates activities related to EuMDR, PMA's, 510(k)'s, and IDE's. Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations. Assists in special projects as needed.
Requirements
Bachelor's degree in a scientific or engineering discipline plus 2 years of experience with regulatory affairs or related. Requires skills and experience in the following:
- Working knowledge of ISO 13485 Medical device standards, EU MDD, EU MDR, and 21 CFR 820.
- Working knowledge of Quality System Regulation and FDA Consensus Standards.
- Good working knowledge of MS Office (Word, Excel, Outlook).
- Familiarity with regulatory planning and strategies for domestic and international submissions/registrations.
- Experience with Endovascular product line.
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits At Getinge
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
