Job Summary:

Sincera Talent Partners is seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join a pioneering company in the medical device industry. This role will be crucial in ensuring that all medical devices comply with international regulatory requirements. You will work closely with product development teams to prepare and submit regulatory documents, manage submissions, and maintain compliance throughout the product lifecycle.

What We Offer:

• Competitive Compensation: A rewarding package reflecting your regulatory expertise.
• Comprehensive Benefits: Including medical, dental, vision, and retirement savings plans.
• Professional Growth: Opportunities to expand your regulatory knowledge and advance your career.
• Work-Life Balance: Enjoy a structured work schedule with paid time off and holidays.
• Innovative Environment: Contribute to the development of life-changing medical technologies in a collaborative setting.

Key Responsibilities:

• Prepare and submit regulatory filings (510(k), PMA, CE marking, etc.) to ensure compliance with global regulations.
• Monitor changes in regulatory requirements and update internal teams on potential impacts.
• Collaborate with R&D, quality, and manufacturing teams to ensure products meet regulatory standards.
• Manage regulatory documentation and maintain accurate records of submissions and approvals.
• Communicate with regulatory agencies to address questions and provide additional information as needed.
• Assist in the development of regulatory strategies for new products and international market expansion.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• 3+ years of experience in regulatory affairs, preferably within the medical device industry.
• Strong understanding of FDA, ISO 13485, and international regulatory requirements.
• Excellent communication skills and attention to detail.
• Experience managing regulatory submissions for medical devices.

Equal Employment Opportunity Statement:

Sincera Talent Partners is dedicated to fostering an inclusive workplace where every employee has the opportunity to succeed. We partner with companies that share our commitment to diversity, ensuring that all qualified applicants are treated fairly and equally, regardless of their background.

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