Premier Brands of America, Inc Hiring for Regulatory Affairs Specialist/Manager (OTC Drugs/Medical Devices) REMOTE Job at Remote Full Time

Westchester, N.Y.- based Premier Brands of America is a privately held manufacturer and marketer of Health & Beauty Aid products serving major food, drug, mass merchant, and e-commerce retailers with both private label and branded lines. The company has achieved success for nearly 50 years through a passion for quality and innovation. Premier is committed to meeting its customers’ needs — going the extra mile to provide the products retailers and consumers want. Today, Premier Brands offers more than 130 foot-care; first aid, and other health & beauty aid products.

Premier is a progressive, dynamic, growth-oriented company. As a second-generation, family-owned, and run company, Premier cares about its family of employees and offers a positive, collaborative work environment. A strong work ethic and team chemistry are valued. Premier is a “flat” organization focused on its next high-growth stage through product innovation and channel expansion.

Job Summary:

The Regulatory Affairs Specialist or Manager, depending on experience, is a new 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 class I/II medical devices, while supporting OTC drug and cosmetics.

Duties and 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.

Required Skills and Abilities:

· 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

Job Type: Full-time

Pay: $80,000.00 – $130,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• FDA regulations: 3 years (Preferred)

Work Location: Remote