Job description

Position Summary The Product Labeling Supervisor is responsible for leading the product labeling team, executing labeling projects, and ensuring label management follows all applicable policies and procedures. In this role you will provide project leadership and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Package Engineering and site Operations. You will work onsite at our Conroe,Texas campus (Houston area) to design medical device product labels and instructions for use (IFU) documents for our medical device product portfolio. What You'll do as a Product Labeling Supervisor • Provides direction on label management processes and project prioritization and execution • Creates and modifies labeling for product instruction for use (IFU) documents, labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines. • Leads activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process. • Monitors changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements • Confers with label package change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective and timely manner • Ensures all requested projects have appropriate labeling resources assigned to enable on-time completion of project goals • Contributes to the development of solutions and best practices for labeling initiatives, including recommending activities involving legacy systems, process improvement, country-specific requirements, labeling standards and regulations, and labeling stakeholders • Communicates with vendors regarding ongoing labeling operations • Works with outside vendors on content translations for labels and IFUs • Controls and manages numerous product labeling project tasks that culminate in release to production via the engineering change process The Experience, Skills and Abilities Needed Required: • Bachelor’s degree in science or communication related field. • In lieu of a degree, high school diploma or GED and 8 years of experience. • Product Labeling and project management experience. • Proficiency with common content management tools and systems. • Experience with document management systems (PLM). • Knowledge of medical device regulations and standards relating to labeling and regulated documentation. Preferred: • Minimum of 3 years product labeling experience and project management experience for medical device or other regulated industry, strongly preferred. • Product labeling design experience, strongly preferred . • Technical writing proficiency is highly desirable with emphasis on medical device product labeling development. • Experience in working within a regulated industry. • Software experience with Propel PLM, Adobe Illustrator, InDesign, preferred • Label Matrix, Nice Label, Bartender, strongly preferred Other: • Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis • Strong interpersonal skills • Excellent written and verbal communication skills • High level of detailed accuracy What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: • Market Competitive pay • Extensive Paid Time Off and added Holidays • Excellent Healthcare, Dental and Vision benefits • Long- and Short-Term Disability coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add- on benefits / discounts for programs such as Pet Insurance • Tuition Reimbursement and continuing education programs • Excellent opportunities for advancement in a stable long-term career Pay range for this opportunity is $90,000 - $115,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

Requirements

Must-haves

You will work onsite at our Conroe,Texas campus (Houston area) to design medical device product labels and instructions for use (IFU) documents for our medical device product portfolio.
What You'll do as a Product Labeling Supervisor
Provides direction on label management processes and project prioritization and execution
Leads activities for new and updated labels from creation, through First Article Inspection (FAI) through the change control process.
Monitors changes in labeling regulations in the US and/or abroad and ensures that labeling meets all medical, legal, and regulatory requirements
Confers with label package change initiators to assess business needs and to determine their requirements to help solve problems in an innovative, cost effective and timely manner
Ensures all requested projects have appropriate labeling resources assigned to enable on-time completion of project goals
Communicates with vendors regarding ongoing labeling operations
Works with outside vendors on content translations for labels and IFUs
Controls and manages numerous product labeling project tasks that culminate in release to production via the engineering change process
The Experience, Skills and Abilities Needed
Bachelor’s degree in science or communication related field.
In lieu of a degree, high school diploma or GED and 8 years of experience.
Product Labeling and project management experience.
Proficiency with common content management tools and systems.
Experience with document management systems (PLM).
Knowledge of medical device regulations and standards relating to labeling and regulated documentation.
Self-motivated and able to work independently with limited supervision, making informed decisions based on analysis

Nice-to-haves

Minimum of 3 years product labeling experience and project management experience for medical device or other regulated industry, strongly preferred.
Product labeling design experience, strongly preferred .
Technical writing proficiency is highly desirable with emphasis on medical device product labeling development.
Experience in working within a regulated industry.
Software experience with Propel PLM, Adobe Illustrator, InDesign, preferred
Label Matrix, Nice Label, Bartender, strongly preferred

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: phenom
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Paid Time Off