Prin Regulatory Affairs Spec

About the role

The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

Responsibilities

• Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio
• Strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations
• Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
• Participate in negotiations and interactions with regulatory authorities during the development and review process
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day by day basis to meet project schedules
• Collaborate with engineering, quality, clinical, marketing, and other functions to fulfill responsibilities
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits
• Maintain regulatory affairs documentation to support compliance with applicable regulatory requirements
• Perform other duties as assigned or required

Requirements

• Minimum Requirements: Bachelor’s degree required, Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
• Nice to Have: Experience successfully achieving FDA clearance through a 510(k) submission, Experience interacting directly with the FDA, Experience managing or contributing to multiple regulatory submissions, Familiarity with medical device regulatory lifecycle management

Qualifications

• Must have a valid U.S. work authorization
• Physical Job Requirements: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

Benefits

Competitive Salary and flexible Benefits Package including Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).