What are the responsibilities and job description for the Remote - Regulatory Affairs Associate position at CooperSurgical?
About CooperSurgical
JOB DESCRIPTION
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 .
Responsibilities
Qualifications
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $70,000 - $95,000. 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.
JOB DESCRIPTION
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 .
Responsibilities
- Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations.
- Identifies, completes, and files all necessary documentation as required for site registrations for both domestic and international locations.
- Reviews Regulatory standards and updates to ensure compliance.
- Collaborates with the Global RA team to maintain the regulatory databases through updating product data and registration data.
- Utilizes the FDA FURLS database to renew annual site establishment listings and obtain device listing data for registrations.
- Processes and updates CFGs through the FDA FURLS database.
- Drafts and updates work instructions relative to the Regulatory Affairs department.
- Notifies Leadership of any regulatory challenges.
- Maintains collaborative relationship with cross functional stake holders, external partners including regulators, and external suppliers.
- Performs additional duties as required by management.
Qualifications
- Bachelor’s degree in Sciences, Engineering, Technical or equivalent.
- 2 years experience in Regulatory and/or Compliance in related industry.
- Working knowledge of Medical Device FDA QSRs, Reproductive Tissue Regulations, Stem Cell Regulations, ISO 9001, Rest of World Regulations (i.e. EU IVDR Canadian Regulations).
- Strong communication and problem-solving skills.
- Advanced computer skills.
- Project organizational skills.
- Passing of background check, which may include verification of prior employment, criminal conviction history, educational and driving records.
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.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $70,000 - $95,000. 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.
Salary : $70,000 - $95,000
