Turkey Job Openings

CooperSurgical

Regulatory Affairs Specialist

Istanbul

FULL TIME

October 22, 2024

Cooper Surgical 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. Cooper Surgical 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.

Cooper Surgical is a wholly-owned subsidiary of Cooper Companies (Nasdaq: COO). Cooper Surgical, 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 .

Extensive knowledge of regulatory requirements and guidelines specific to medical devices in META.
Demonstrated experience in regulatory affairs within the medical devices industry, including handling new registrations, ongoing compliance, change notifications and regulatory assessments.
Strong analytical and problem-solving skills to monitor and interpret regulatory developments and assess their potential impact.
Ability to collaborate cross-functionally to ensure integration of regulatory requirements into projects and commercialization processes.
Excellent communication skills.
High level of attention to detail and strong organizational skills.
Intermediate or above skills in the use of Excel, Word, Power Point, Outlook.

Experience:
+ 2 years of experience in the medical devices industry within RA.

Education:

Bachelor’s or master’s degree in life sciences, biomedical engineering, pharmacy, or a related discipline.

Responsible for supporting RA activities in Middle East, Turkey & Africa (META) region for Fertility Solutions products to ensure compliance with the region’s regulatory requirements.

Support RA activities in META region by collaborating with internal and external relevant stakeholders to ensure regulatory requirements for META are processed timely and efficiently to ensure compliance with markets regulations and ensure successful business continuity.
Location:

Hybrid
Office based in Istanbul, Turkey.

Essential Functions & Accountabilities:

Ensure compliance with local regulatory requirements in Middle East, Turkey and Africa for medical devices marketed or intended to be marketed.
Support with the submissions management including new registrations and registrations maintenance, with relevant channel partners and health authorities across the region.
Responsible for conducting change notification and regulatory assessments.
Monitor proactively regulatory developments and changes in legislation in META, assess potential impact and advising internal relevant stakeholders.
Work closely with relevant internal departments to ensure regulatory requirements for META are integrated into necessary projects or commercialization process.
Maintain comprehensive and accurate records for all regulatory activities and submissions, ensuring documentation meets requirements of company standards.
Collaborate with global Regulatory Affairs teams as needed to ensure alignment of activities and sharing best practices.

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