Regulatory Affairs Specialist

OBP Medical • Full-time • Trumbull, CT, US • 4d ago

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Technical Documentation: Write, analyze, and edit technical documents to support country-specific Regulatory submissions.
Regulatory Submissions: Compile submissions in a format consistent with applicable guidance documents, including submissions in the USA, Canada, Europe, and other countries.
Regulatory Files: Create, maintain and update Regulatory authorizations, such as 510(k)s, Canadian medical device licenses, and CE dossiers.
Compliance: Ensure appropriate maintenance of registrations, including renewals, device listings, site registrations, supplements for changes, and annual reports.
Communication: Work with other departments and communicate submission requirements when documents are needed for Regulatory submission.
Regulatory Climate: Stay abreast of Regulatory procedures and changes in the Regulatory climate.
Support change control process.
Perform labeling Regulatory reviews/approvals as required.
Develop and maintain Regulatory procedures.
Support internal and external Regulatory agency audits, providing Regulatory input to minimize potential findings of non-compliance.
Attend and/or lead Regulatory meetings.
Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Biology, Chemistry, Engineering, Regulatory Science).
Certificates, Licenses, Registrations.
3+ years’ Medical Device Regulatory experience.
Experience with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other international Regulatory requirements (e.g. EU Medical Device Regulations).
Experience with FDA submissions (510(k), PMA, etc.), CE marking submissions, and international product registrations.
Coordinate with applicable stakeholders, to support Regulatory submissions.
Work with various systems and tools within Regulatory (e.g., RIM, ERP, etc.)
Able to work independently as well as part of a team
Adaptable and flexible
Attention to detail and ability to manage multiple projects simultaneously.

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.