Regulatory Affairs Specialist

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. 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

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Department / Functional Area : Regulatory Affairs

Experience : years

Vacancy : 1