Sr. Regulatory Affairs Specialist (Defined Term)

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 Overview

Responsible for internal, domestic and international compliance activities. Prepare comprehensive regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management., project teams and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management.

Job Responsibilities and Essential Duties

• Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management.
• Prepares Regulatory strategy/plans and requirements.
• Prepares documentation and coordinates activities related to EuMDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s and IEDs.
• Prepares worldwide regulatory submissions/registrations including collecting information and documentation for submissions to regulatory agencies.
• Update/maintain basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency.
• Participates in the review and disposition of labeling, promotional material and product modifications.
• 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.
• Complies and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirement and tracks timeline through review process to ensure timely submission.
• Participates in cross-functional departmental team projects and products development activities/meetings.
• Support with Field Correction and Recall activities
• Responsible for FDA/ISO/MDD/MDR/CMDR compliance documentation
• Participates in and support internal and third-party audits
• Assists in special projects as needed
• Contributes to team effort by accomplishing related duties as requested

Minimum Requirements

• Bachelor’s Degree and a minimum four years of directly related experience in Regulatory Affairs in a medical device environment, or a minimum ten years of directly related experience in Regulatory Affairs in a medical device environment.
• Experience wit the preparation, submissions and approval for medical devices is required including 410(k) or PMA.
• Understands the requirements of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR and ISO 13485.
• Proficient computer skills, including MS office applications (Word/Excel) are required.

Required Knowledge, Skills and Abilities

• Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
• Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
• Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills.
• Ability to represent Regulatory Affairs to other departments.
• Working knowledge of principle compliance focused ISO Standards (13485, 14971, 62366) and the use of ISO Standards as special controls.

Supervision/Management Of Others: None

Internal and External Contacts / Relationships

• Maintains effective relationships with internal customers.
• Build relationships and participates as a member of a cross-functional product development team.
• Professionally negotiate/communicate directly with regulatory entities (e.g., governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles

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 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

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.