About the job

Job Description Summary

We are looking to hire a Regulatory Affairs to support the Medical Device unit. The role will report to the Regulatory Team Leader.

About The Role

The Regulatory Affairs will be responsible for handling document compilation for registration, renewal, amendment, and variations of the Medical Device portfolio; as well as respond to regulatory related customer requests.

Main Responsibilities

·        Provides regulatory input and technical guidance on global regulatory requirements to product development teams

·        Leads in the development of regulatory strategy and updates strategy based upon regulatory changes

·        Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

·        Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines

·        Evaluates device modifications and takes appropriate action to ensure global product compliance.

·        Identifies the need for new regulatory procedures and participates in development and implementation

·        Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

·        Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

·        Follow up on the 2017/745 Medical Device Regulation and the 93/42 Medical Device Directive requirements.

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About You

·        A Bachelor’s Degree (B.S or B.A) is required.

·        A minimum of 2 years of Regulatory Affairs experience.

·        Experience with the 2017/745 Medical Device Regulation and the 93/42 Medical Device Directive is essential.

·        Türkiye regulatory submission experience required.

·        Fluent Turkish and English language proficiency required.

·        Ability to understand and explain detailed regulatory compliance requirements and/or issues.

·        Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

·        Ability to analyze and resolve non-routine regulatory issues using independent judgment.

·        Excellent analytical and writing skills.

·        Excellent interpersonal, written, and oral communication skills.

·        Effective organizational skills.

·        Advanced PC skills with proficiency in Microsoft office Word and Excel.