Regulatory Affairs Specialist
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
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. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at .
Scope:
As Regulatory Affairs Specialist you will take ownership of regulatory activities in the US Canadian and Australian markets. This includes regulatory submissions renewals license notifications and product change assessments (letters-to-file / not-to-file). You will also contribute to 510(k) submissions ensuring documentation is accurate compliant and delivered on time.
Responsibilities
Job Summary:
Will participate regulatory affairs projects for CooperSurgical products both Fertility & and Medical
Devices in EU (MDR) and RoW countries
Ensure effective project management for product registration and re-registration in
collaboration with Notified bodies local regulatory authorities registration partners
certificated labs and global CSI Regulatory Affairs team
Provide timely management of necessary local certification and renewals of custom
declaration documentation.
Run product
Proactively monitor changes in the local regulation and share the information with global CSI
Regulatory Affairs team and local commercial team.
Participate in training activities organized by the local authorities on regulatory matters!
Maintain and update RD database including dossiers archiving.
Work closely as part of the global CSI Regulatory Affairs team to ensure alignment of activities
and sharing of global best practices. Join Regulatory Affairs meetings as deemed appropriate.
Work closely with the local commercial distribution and service teams and provide necessary
trainings.
FDA Expertise is required
Essential Functions & Accountabilities:
Global Regulatory Projects in RoW countries
Responsible for all regulatory activities for IVF media in Australia Canada & US
Rimsys System
Archiving of RA & CA
Product registrations in RoW
Travel:
N/A
Qualifications
Qualifications
Knowledge Skills and Abilities:
Strong Regulatory
Strong Project management skills
Good communication and negotiations skills
Good IT skills
Work Environment:
Office based in Denmark
Experience:
2 years of experience from the medical device industry within RA
Education:
Master degree in Life Science or an equivalent education.
As an employee of CooperSurgical youll receive a competitive total compensation package. We believe your rewards go beyond your paycheck so we offer a great compensation package supplemental medical coverage pension contributions parental leave fertility benefits paid vacation and holidays wellness programs and other perks that support your health and work-life balance. Please visit us at to learn more about CooperSurgical and the benefits of joining 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 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:
IC
Key Skills
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- IT Support
About Company
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