Product Surveillance MDR Specialist

CooperSurgical

Trumbull, CT - Remote

Position Summary:

The Product Surveillance MDR Specialist reviews and evaluates product complaint records related to alleged quality issues, patient events as well as, submission of regulatory reports to heath authorities. The Product Surveillance MDR Specialist is experienced in complaint handling activities and identifying reportable complaints according to current FDA and international reporting regulations. The MDR specialist will draft with input from cross-functional team members like engineering and investigators and submit such reports as required to competent regulatory authorities.

The Product Surveillance MDR Specialist must have excellent communication and customer service skills, and demonstrate the ability to evaluate, disseminate, and present information from a global perspective.

You Will:

1. Retrospective review of existing closed reportable complaints to determine if a supplemental/final report is required.

2. If submission is required complete and submit incident reports as needed.

3. Ensure the record is accurate and complete.

4. Collaborate with subject matter experts as needed.

6. Well versed with compliance requirements for CFR, ISO, MDSAP, EU MDR, and other regulations.

7. Performs additional duties or assignments as required by management.

You Have:

1. Three years of previous experience required in MDR and Vigilance reporting.

2. Bachelor's Degree preferred or equivalent experience in healthcare related or technical field.

3. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

4. Ability to work independently and in a team setting.

5. Excellent verbal, written, presentation skills with attention to detail and the ability to communicate business issues clearly.

6. Strong operating knowledge of MS Office suite (Outlook, Word, & Excel).

7. Experience with MasterControl is a plus.

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:

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.