Senior Regulatory Affairs Specialist

At HealthFirst, we have been providing compliance solutions to dental and medical practices for over 50 years. From essential medications, devices, and supplies to advanced services, training and software, infection prevention, and control products, our mission is to guarantee the right compliance products, services and programs are there, whenever, and wherever our customers need them. We have a great opportunity for a Sr. Regulatory Affairs Specialist to join our team.

This position is responsible for handling a wide range of regulatory affairs activities in support of the Sr. 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 and assist the QA/RA Sr. Manager with 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. Manager of QA/RA

WORK EXPERIENCE:

• 4-6 years of relevant experience in a Regulatory Affairs role in a medical device industry is required.
• Familiarity with medical device regulations (21 CFR, ISO 13485) requirements is essential.
• Experience authoring and submitting medical device registrations/licenses/submissions.

EDUCATION:

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

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 10-15%
• Position typically works in an office environment
• 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 to 15 pounds

HealthFirst tis 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.