Career Opportunities Getinge Group Regulatory Affairs Specialist II 34625

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 lifesaving 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 PMAs 510(k)s and IDEs. 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:

Bachelors 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.

About us

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 12000 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

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity pregnancy genetic information national origin disability protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.