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
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