[Hiring] Principal Regulatory Affairs Specialist @Getinge

Role Description

The Principal Regulatory Affairs Labeling Specialist is the regulatory subject matter expert and lead for medical device labeling and Unique Device Identification (UDI) for SWICC consumable medical devices. This role manages a large volume of labels and many label versions across SWICC consumables and guides teams on the labeling requirements.

• Leads all regulatory labeling strategy discussions.
• Manages a high volume of labels and label versions for SWICC consumables.
• Owns regulatory intelligence for labeling.
• Serves as the global labeling expert for SWICC consumables.
• Maintains a current view of labeling, language, and symbol requirements by region.
• Assesses regulatory changes and new requirements against existing SWICC consumable labeling.
• Defines the regulatory labeling requirements for each SWICC consumable product family.
• Develops and/or reviews labeling and promotional materials for regulatory compliance.
• Serves as the UDI subject matter expert for SWICC consumables.
• Acts as, or supports, the accountable person for GUDID and EUDAMED data submissions.
• Supports engineering and labeling changes by routing the regulatory assessment.
• Provides leadership and expert guidance to various teams on new product development.
• Provides expert support with all 510(k), De Novo, and/or EU MDR technical documentation.
• Authors and/or contributes to labeling and UDI procedures, work instructions, and style guides.
• Serves as the labeling and UDI subject matter expert with internal and external auditors.
• Develops and delivers training on labeling and UDI requirements.
• Reviews labeling redlines and verifies translations for accuracy and compliance.
• Assists in special projects as needed.

Qualifications

• Expert knowledge of labeling, PLM and change control, and MS Office applications.
• Team player who communicates and collaborates proactively with various cross-functional teams.
• Expert ability to interpret regulations and explain labeling requirements.
• Able to work with international business units and local regulatory colleagues.
• Detail-oriented with excellent organizational skills.
• Strong interpersonal communication and negotiation skills.

Requirements

• Expert knowledge of FDA 21 CFR Part 801, 21 CFR Part 830, and EU MDR 2017/745.
• Expert knowledge of international medical device labeling requirements.
• Experience with single-use consumable medical devices.
• Hands-on experience with UDI, GS1/GTIN, GUDID, and EUDAMED data requirements.
• Minimum 7 years of medical device regulatory affairs experience.
• Experience managing a high volume of labels and label versions.
• Bachelor's degree in a scientific, engineering, or related field.

Benefits

• 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.