Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 womens healthcare providers including testing and treatment options.
CooperSurgical is a whollyowned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical headquartered in Trumbull CT produces and markets a wide array of products and services for use by womens health care clinicians. More information can be found atwww.coopersurgical.
Responsibilities
- Technical Documentation: Write analyze and edit technical documents to support countryspecific 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 noncompliance.
- Attend and/or lead Regulatory meetings.
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Qualifications
- Bachelors 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 youll 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 atwww.coopersurgicalto 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 viaemail 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
