Regulatory Affairs Specialist – Medical Devices - $110k - $120k and 8%

NO CTC

We are seeking an experienced Regulatory Affairs Specialist to join a dynamic team in the medical device industry. Working knowledge of FDA 510(k) submissions is a must. This role offers an exciting opportunity to contribute to regulatory compliance and support a company committed to innovation in healthcare solutions.

About the Role:

As a Regulatory Affairs Specialist, you will play a critical role in assembling and managing regulatory submissions, maintaining compliance with global regulations, and supporting cross-functional teams. Your expertise will ensure that regulatory policies and procedures align with industry standards and drive successful product approvals.

Key Responsibilities:

• Prepare, review, and assemble regulatory documents for submissions in compliance with relevant guidelines.
• Manage information for U.S. and international submissions, including device master files, technical files, annual reports, and amendments.
• Maintain and update regulatory databases and submission records.
• Communicate with regulatory agencies to clarify submission requirements and ensure compliance.
• Review and recommend regulatory policies, SOPs, and protocols to maintain adherence to FDA and international standards.
• Stay updated on regulatory rules, guidance documents, and standards, and provide interpretive assistance.
• Write or revise SOPs, work instructions, and policies to align with evolving regulatory requirements.
• Participate in audits, product recalls, and regulatory training programs.
• Collaborate with internal teams to develop and manage regulatory timelines and responses.

Qualifications & Requirements:

• 8+ years of experience in the medical device industry.
• Bachelor’s degree in a related field or equivalent combination of education and experience.
• Strong knowledge of 21 CFR, FDA guidelines, GMPs, and international regulatory standards.
• Proficiency in MS Word, Excel, and PowerPoint.
• Excellent verbal and written communication skills in English.
• Strong organizational, interpretive, and interpersonal skills.
• Ability to manage multiple tasks and work effectively in cross-functional teams.
• Attention to detail and commitment to quality.