Specialist, Regulatory Affairs Graphic Design

Company: West Pharmaceutical Services
Location: Exton
Posted on: May 28, 2023

Job Description:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.
At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.
Job Summary:
In this role, the Specialist, RA Graphic Design will coordinate and create packaging labeling and instructional artwork as well as support internal functional teams with review and approval of artwork and content. You will work to assure all labeling is designed with the required written content and illustrations in accordance with the product design and applicable regulatory requirements.
Essential Duties and Responsibilities:

• Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on creating packaging labeling and instructional artwork for medical devices for device development and submission to Health Authorities.
• Ensure that labeling, including promotional materials, meet all medical, legal and regulatory requirements in compliance with regulations, guidelines and procedures.
• Develops editor's copies and review artwork ensuring that all components meet the appropriate labeling requirements and guidelines. Gathers and evaluates all relevant information to support labeling changes for each project and maintains detailed audit trail.
• Participate in global labeling projects to completion, working closely with Regulatory Affairs, Quality Assurance, Research & Development and Clinical teams.
• Facilitates the review and approval processes for new and post market change artwork and labeling from development through final proofs, including translations.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
• Monitor and assess regulatory requirements and recommend solutions and best practices for implementation and control of compliant labeling.
• Monitor, evaluate and recommend improvements to regulatory and quality systems tools and/or policies supporting the labeling process.
• Takes the initiative to identify and solve problems, leading the resolution process for any issues encountered during labeling development.
• Maintain working knowledge of computer software programs including CAD, MS Word, MS Excel, MS PowerPoint, Adobe, SharePoint, SAP and MasterControl and others as required.
• Other duties as assigned. Basic Qualifications:
  • Education: Bachelor's degree in an appropriate discipline in either life science/ technical (engineering) or Graphic Design with related work experience.
  • Experience: Bachelor's with 3-5 years in the pharmaceutical/medical device industry, with specific product labeling experience and/or demonstrated ability to process labeling within the skills defined.
    Preferred Knowledge, Skills and Abilities:
    • Strong knowledge of graphic design software applications such as, Adobe Illustrator and CAD.
    • Current knowledge of US and International Regulations (MDR (Regulation (EU) 2017/745), FDA CFR 21 CFR 820, ISO 15223:2022, ISO 13485, IEC 60601, etc.) and the ability to stay abreast of regulations pertinent to medical devices and combination products.
    • Solution-driven attitude, ability to autonomously develop a course of action leading to a beneficial outcome.
      • Ability to effectively operate in a multicultural environment which requires negotiation, collaboration and adaptation.
        • Excellent interpersonal, communication and listening skills.
        • Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
        • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
        • Able to comply with the company's safety policy at all times
        • Able to comply with the company's quality policy at all times. Travel Requirements:
          • Must be able to travel up to 5 - 10 % of the time (meeting, trainings, projects, industry events), including international travel. Physical & Mental Requirements:
            • If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
            • Sedentary environment; ability to work in an office; may need to stand or sit for extended periods of time.
            • Ability to comprehend principles of math, science, engineering, and medical device use.
            • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
            • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
            • Ability to review, collate, describe, and summarize scientific and technical data.
            • Ability to organize complex information and combine pieces of information to form general rules or conclusions.
            • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
            • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
            • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
            • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
              West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Keywords: West Pharmaceutical Services, Wilmington , Specialist, Regulatory Affairs Graphic Design, Design, Graphic Design & CAD , Exton, Delaware