Jobs in America

Senior Labeling Specialist (Quality & Regulatory Affairs) - Remote

Posted: December 2, 2023 Expired: February 18, 2024
Long
FULL TIME
Bachelor Degree 5 Year

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.


Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.


Our Core Values are reflected in all we do:
Integrity – Empathy – Agility – Unity – Long-Term View


We deliver on our purpose and our core values by staying True to Life.

Job Description

Provide technical leadership and support in the areas of labeling design and development, artwork control, and labeling policy and procedures.


Leads or participates on cross-functional assignments and provides technical labeling design/development for new product and process development, and sustaining engineering activities.


Create new labeling policy around label content development, labeling assembly drawings and artwork control; as well as potential updates to existing policy.

Job Duties
  • Work collaboratively with package engineering, document control, and product development team(s) to develop new product labeling as an extended team member to regulatory affairs.
  • Plans labeling projects and manages scope deliverables and timelines using project management tools while managing communication with stakeholders and managing project teams to keep deliverables aligned with business objectives and priorities.
  • Manages change controls for labeling release and updates.
  • Effectively engages with the project team and seeks out support when appropriate.
  • Understands impact(s) of labeling design and development as part of overall product and packaging development.
  • Standardize labeling printing technology software and labeling formatting/templates across sites; as well as labeling content development.
  • Fosters a collaborative environment and gains support and cooperation for ideas proposals projects and solutions to accomplish goals.
  • Continuously builds knowledge keeping up to date on the technical or procedural aspects of labeling and labeling regulations.
  • Utilizes good documentation practices (i.e. revision control red lining Agile release)
  • Follows GWI’s, GSOP and owns MP's to ensure control of product/process design
  • Assist in development of labeling processes and policies.
  • All other essential related duties as required.
Job Qualifications

Required:

  • Bachelor’s degree (B.S.) in graphic design, packaging engineering, regulatory affairs, or related life sciences field.
  • Minimum of 5 years of professional experience within the medical device industry supporting labeling or related area.
  • Experience supporting labeling design and process development on new product development teams.
  • Experience working in integrated cross-functional product development teams.
  • Knowledge of FDA and EU regulatory labeling requirements (21CFR801, MDD, MDR, etc.). Additional regions are a plus.
  • Knowledge of ISO 15223 and ISO20417
  • The candidate must be proficient with the use of Microsoft Office applications.
  • Experience with graphic design and labeling applications (Adobe Creative Cloud, FrameMaker, LabelView, Loftware, etc.)
  • Time management skills allowing for working on multiple projects at once
  • Understanding of risk analysis
  • Travel – less than 10%


Preferred:

  • Process development and/or manufacturing experience preferred.


** The anticipated base pay range for this full-time position working at this location is $81,958.00 - $110,642.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.


#LI-Hybrid

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**
  • US Only

**Limited locations


We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.


About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.


Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.


Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.


Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.


Posting Notes: || United States (US) || Massachusetts (US-MA) || Southborough ||

This job was expired