Regulatory Affairs Manager

Title:

Regulatory Affairs Specialist/Manager
Salary:

$110,000-$140,000
Benefits:

401(k), Dental insurance, Health insurance, PTO, Vision insurance, 3 weeks PTO, Flexible Spending Account, Holiday bonus plan
Work Schedule:

HYBRID
Location:

Westchester, NY
Position Type:

Permanent/Direct-Hire

Company Overview:

Rapidly growing world-class manufacturer providing high-quality, effective products for health and wellness is in search of a Regulatory Affairs Manager. The Regulatory Affairs Manager is a position that mainly supports the business operations in the areas of regulatory compliance and is responsible for planning, coordinating and implementing regulatory strategies related to the manufacture, packaging and distribution of our OTC (monographed) drugs, OTC medical devices (class I/II), and cosmetics.

Responsibilities:
• Interact with state and national regulatory agencies on a regular basis.
• Keep up to date on regulatory policy and procedural changes that could affect the company’s operations.
• Work with cross-functional teams to help them keep compliant with regulatory aspects of new product development and on-market items.
• Review all labeling and promotional materials through all mediums to ensure they’re truthful and fair.
• Author and maintain 510(k), MDRs, DHRs, UDIs, and other technical documentation for medical devices.
• Prepare device listings, GUDID registration, site registrations, renewal fees, and other regulatory submissions.
• Interact with suppliers with respect to required testing and compiling of Regulatory documentation for existing and new formulas, along with tracking of any changes.
• Manage the consumer, safety, analytical, and clinical testing needed for products and their claims’ substantiations.
• Procure and file licenses and legal documents regarding the sales and transport of company's products.
• Support internal, client, vendor, and FDA audits, along with the implementations of corrective actions.
• Identify to management of any major risk assessments such as a need for market recall/withdrawals.
• Collaborate with cross functional teams to log, investigate, and report customer complaints and adverse reactions.
• Optimize internal processes with continuous improvement and updated SOPs.

REQUIREMENTS:
• Thorough knowledge of FDA (especially CFR Part 800s), FTC, Prop 65, GMP, and ISO standards including those governing the manufacturing, packaging, labeling and marking of company’s products (OTC drugs, medical devices and personal care products). Knowledge of Health Canada guidelines and other international experience is a plus.
• Excellent organizational skills, high attention to detail, ability to work on multiple tasks in a fast-moving, time-sensitive environment with minimal supervision.
• Strong analytical, communication (written and verbal), and interpersonal skills.
• Ability to work in a computerized environment, with good knowledge of MS Suite, Internet, databases, etc.

Education and Experience:
• 3-7 years of Regulatory Affairs experience in OTC medical devices. OTC drugs and cosmetics experience is a plus.
-Bachelor’s degree in a Science or Engineering degree is preferred.

#J-18808-Ljbffr