Regulatory & Product Safety Associate

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

Plays a critical role in providing regulatory and product safety support across PDI's diverse portfolio of drugs (NDA/OTC), medical devices (Class I & II), disinfectants, cosmetics, and cleaning products. The incumbent ensures safety compliance for both new and existing products, meeting all required raw material and finished product safety standards, and ensuring full compliance with regulatory requirements across key markets. This role also involves generating Safety Data Sheets (SDS) in alignment with the most current compliance requirements. By contributing to PDI's commitment to safety and regulatory excellence, is well-positioned for career growth in a dynamic, fast-paced, and challenging work environment.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Supports assigned projects and existing product portfolio by clearing raw materials and final formulae to ensure consumer safety and regulatory compliance.
• Support reviews of current products against new regulatory and product safety requirements to ensure their continued compliance with US and Canadian regulatory requirements for Cosmetics, Medical Device, Disinfectants/Biocides, Drugs OTC/NDA, and general cleaners.
• Address customer inquiries on raw materials and formulae used in products across product portfolio
• Coordinates information with R&D counterparts and suppliers to author and maintain timely and accurate Safety Data Sheets (SDS)
• Consults with line manager, internal experts, and external consultants to define product safety requirements and timings for new product initiatives based on their regulatory positioning
• Collects and collates required safety data and documents in support of product core dossier/technical file relating to projects; partners with the dossier/technical file authors to ensure consistency and 'right first time' approach
• Collaborates with Regulatory colleagues in ensuring safety/clinical claims substantiation

PERFORMANCE MEASUREMENTS

• Achievement: Consistent delivery of high-quality technical work on time and with minimal issues.
• Ownership: Independent and proactive management of assigned projects to ensure timely completion.
• Collaboration: Effective teamwork and communication across functions to achieve shared objectives.
• Innovation: Introduction of creative solutions and contributions to process improvements and new product ideas.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• BA/BS degree in the natural sciences (preferred)
• Bachelor's degree in natural sciences, chemistry, toxicology, or a related field (preferred)

REQUIRED KNOWLEDGE:

• Chemicals knowledge
• Fundamentals of safety risk assessment
• Regulation knowledge
• Safety Data Sheet authoring a must
• Chemical Safety and Compliance Knowledge: Understanding of chemicals, raw materials, and their regulatory impacts across product categories.
• Safety Risk Assessment: Foundational understanding of hazard identification and mitigation strategies.
• Regulatory Knowledge: Familiarity with US, Canadian, and international regulatory frameworks (e.g., FDA, EPA, Health Canada, EU).
• Safety Data Sheet (SDS) Authoring: Proficiency in generating and maintaining SDS in compliance with GHS and other regional standards (mandatory).

EXPERIENCE REQUIRED:

• A minimum of 2-5 years of relevant work experience
• Experience in Drug, Biocidal, Cosmetic product safety assessment preferred
• 2-5 years of experience in product safety or regulatory affairs. Experience with safety assessment for Drugs (OTC/NDA), Biocides, Cosmetics, or Cleaning Products preferred.
• Prior experience in consumer or healthcare product industries is a plus.

SKILLS/ABILITIES:

• Strong people skills and ability to work effectively within a team
• Initiative-taking and results oriented with a bias for detail
• Ability to multi-task, with strong time management skills
• Ability to display agility and adapt to change
• Excellent communication and networking skills
• Proactive, independent and a willingness to take on new challenges
• Strong analytical skills with attention to detail in safety and regulatory assessments.
• Exceptional organizational and project management skills for handling multiple priorities.
• Effective interpersonal and communication skills for cross-functional collaboration.
• Proven adaptability in a dynamic, fast-paced environment.

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.

SALARY RANGE

• $65,000 - $75,000 annually

PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options