Psur Technical Writer Jobs

PSUR Technical Writer

CooperSurgical, Inc

Remote - Trumbull, CT

Position Summary
The Periodic Safety Update Report (PSUR) Technical Writer will author Periodic Safety Update Reports and collaborate with cross-functional teams as assigned.

Essential Functions

• Report to the Sr. Post Market Surveillance Manager any risks identified related to the required documents
• Manage the deliverables as assigned
• Collaborate with Cross-Functional Teams like Clinical Affairs, Design Quality Engineering, and Manufacturing Operations, etc.
• Support all EU MDR 2017/745 activities as required for finalization of various Technical Documents

Qualifications:

• 100% Remote with a laptop
• Bachelor's degree required (Preferably in Science)
• Solid understanding of the Quality Management System and the associated interrelationships
• Knowledge of EU MDR 2017/745, ISO 13485 and 14971, 21 CFR Parts 820 and 803
• Collaboration via Teams
• Excellent communication and collaboration skills
• At minimum 5 years’ experience in Quality Assurance/Regulatory Affairs environments

About CooperSurgical:

CooperSurgical is a leader in manufacturing and marketing multiple trusted and innovative brands that assist clinicians in improving the health of women, babies and families worldwide. Through an aggressive growth and diversification strategy, CooperSurgical has evolved its portfolio of over 600 products to include products and services used primarily by obstetricians and gynecologists in surgical and medical procedures wherever they occur: in hospitals, surgical centers, medical offices and fertility clinics.

Our Benefits:

For U.S. locations that require disclosure of compensation, the yearly starting base pay for this contract role is between $55 and 60 per hour. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.