Position: Regulatory Affairs Specialist
Location: IN
Duration: 5 Months
Key Responsibilities:
Prepare, review, and maintain regulatory documentation using a paper-based system to ensure alignment with international regulatory standards.
Manage and support international product registrations and approvals across Canada, LATAM, APAC, and the Middle East regions.
Liaise with regional regulatory authorities to monitor and adapt to evolving regulatory requirements.
Assist in the preparation, submission, and maintenance of regulatory filings, renewals, and post-market compliance activities for EU Class IIa dental devices and other international markets.
Provide strategic regulatory input to cross-functional teams to facilitate efficient product registration and market access.
Conduct regulatory gap analyses and propose actionable strategies to maintain compliance across diverse global markets.
Partner with local distributors and regulatory bodies to expedite product approvals and resolve regulatory challenges.
Maintain accurate, up-to-date regulatory records and ensure timely documentation updates for all international submissions.
Qualifications:
The ideal candidate will have at least 3 years of experience in regulatory affairs within the medical device industry, with a strong focus on international submissions and approvals.
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