Job description

Senior Regulatory Affairs Specialist NEEDED IN Waukegan,IL!

Stradis Healthcare, a subsidiary of Henry Schein Inc, is a team of focused individuals with a passion for advancing healthcare delivery, contributing to high-quality patient care, and creating efficiencies for healthcare providers. We specialize in providing medical device packaging and custom procedure kits/trays to surgical centers, private practices, oral surgeons and a multitude of other specialties nationwide. If joining this community of ambitious leaders interests you, apply below.

JOB OVERVIEW:

This position is responsible for handling a wide range of regulatory affairs activities in our dental and medical businesses in support of the Manager(s) of QA/RA. This position directly investigates and completes regulatory affairs activities, assists in the development of procedures, and coordinates with different departments to ensure regulatory requirements are met. Responsible to ensure general compliance with Federal, and State regulations applicable to the manufacture and distribution of medical devices including facility licensure and product registration. Communications with regulatory bodies on significant matters, including formal responses to regulators on submissions, with supervision. Communicates regulatory requirements to functional leaders, exercises judgment on when to escalate regulatory queries for managerial input.

KEY RESPONSIBILITIES:

• Prepare and submit product registration documents, including FDA listings and GUDID
• Identify and obtain regulatory data and requirements
• Ensure requirements are effectively presented and followed for the registration of products worldwide.
• Manage multiple regulatory affairs projects related to meeting requirements
• Represent regulatory affairs in cross-functional project teams, plan and schedule for regulatory deliverables, and participate in projects through completion as needed.
• Use influence and persuasion as needed to gain answers on projects and provide regulatory affairs deliverables on schedule
• Identify the least burdensome approach to promote speed to market and compliance with applicable regulations
• Review and approve labeling and promotional materials.
• Manage regulatory compliance activities such as HHEs, adverse event reporting and recall execution and reporting.
• Monitor and communicate changes to regulations, legislation, guidance documents and policy to determine impact to the organization.
• Combine knowledge of scientific, regulatory and business issues to meet required legislations
• Provide multi-department/site level regulatory affairs coverage and be generally recognized as an expert resource
• Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance
• Utilize technical regulatory skills to propose strategies on complex issues
• Interface with a variety of management levels on regulatory affairs matters, often requiring the coordination of activity across functional groups
• Other activities as assigned by the Sr. Director of QA/RA

WORK EXPERIENCE:

• Recent experience in medical device industry is required.
• Familiarity with medical device regulations (21 CFR, ISO 13485) requirements is essential.

EDUCATION:

• Bachelor's degree (B.S.) from four-year College or University in Applied Science or Mathematics preferred.
• Master of Science/Engineering or RAC certification preferred. Regulatory Affairs Certification

KNOWLEDGE, SKILLS & COMPETENCIES:

• Ability to read and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.
• Ability to create reports, business correspondence, and procedure manuals

• Ability to write, critique and review labeling

• Proficient producing well thought out technical reports
• Ability to effectively present information and respond to questions verbally, in writing, and in group presentations
• Ability to develop and articulate risk analyses
• Must be skilled in Microsoft Word, Excel, Outlook, Power Point, and Adobe Acrobat

TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS:

• Travel – typically not required
• Position typically works in an office environment whether on site or remote where environmental conditions are stable
• While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds

We thank our team members by offering a competitive salary, comprehensive benefits package, generous PTO, 401k with company match, and much, much more!

Stradis Healthcare, LLC is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Job Type: Full-time

Pay: $100,000.00 - $114,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Waukegan, IL 60085: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 2 years (Preferred)
• Medical Device: 2 years (Preferred)

Work Location: One location

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