At STERIS we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
As the Labeling Project Specialist in our Plymouth Minnesota location you will be responsible for the overall coordination development and execution of Global Labeling Projects. 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.
This is a Hybrid position that requires onsite work in our Plymouth Minnesota location with the option to work from home a few days per week during core business hours Monday through Friday.
What Youll do as a Product Labeling Specialist
- Create and modify labeling for product labels cartons and other related materials ensuring that they meet all medical legal and regulatory requirements for medical devices and follow the established design format labeling style guidelines and branding guidelines.
- Build sustainable relationships of trust through open and collaborative communications.
- Maintain positive and cooperative communications and collaborations with all levels of employees customers contractors and vendors.
- Use information exchange influence and active persuasion without direct exercise of command to gain cooperation of other parties.
- Support a cross-functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Work on commercialized and new product introduction labels and instructions for use (IFUs).
- Work with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
- Collaborate with label change request initiators to plan prepare and submit complete and accurate change requests within a PLM system. While ensuring correct implementation strategy is applied.
- Manage multiple concurrent deadlines.
- Provide guidance to management in identifying/executing alternate strategies to facilitate or accelerate delivery.
- Communicate with internal and external customers and vendors regarding ongoing operations.
- Strive for continuous improvement and consistency in deliverables.
- Maintain knowledge of new developments in packaging and labeling technologies.
- Comply with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and tasks and assignments.
The Experience Skills and Abilities Needed
Required:
- Bachelors degree in science-related discipline.
- Minimum of 2 years labeling experience.
- Experience with document management systems and (PLM) Product Label Management Systems such as Nice Label Bartender or similar systems.
- Proficiency in MS Office applications such as Word Excel PowerPoint and Outlook.
Preferred:
- Developing labeling for medical devices for FDA global markets and ISO standards.
- Experience in Adobe Creative Cloud Applications including InDesign and Illustrator.
- Unique Device Identifiers (UDI) /Global Trade Item Numbers (GTIN) requirements.
- Knowledge of medical device regulations and standards relating to labeling and regulated documentation.
Other:
- Strong interpersonal skills to quickly build relationships with cross functional teams and communicate effectively with other functional groups.
- Ability to influence others and operate effectively with ambiguous situations.
- Customer orientation and ability to adapt/respond quickly and efficiently.
- Must be able to listen to the customers requirements desires and concerns and recommend solutions.
- Self-motivated and able to work independently with limited supervision making informed decisions based on analysis.
- Action-oriented and customer-focused to deliver consistent quality results.
- Ability to function well under pressure.
- Ability to multi-task organize and judge priorities. While being flexible to balance day-to-day deliveries at the same time as unanticipated activities.
- 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
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Pay range for this opportunity is$72675.00-$94050.00.This position is eligible forbonus 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
STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures devices vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B publicly traded (NYSE: STE) company with approximately 18000 associates and Customers in more than 100 countries.
If you need assistance completing the application process please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs 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.
The full affirmative action program absent the data metrics required by 60-741.44(k) shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your locations HR Office during normal business hours.
Required Experience:
Unclear Seniority