Regulatory affair Manager - Medical devices

• Develop and implement regulatory strategies for product development, registration, and commercialization.
• Prepare and submit regulatory submissions, including Investigational New Drug (IND), New Drug Application (NDA), 510(k), Pre-Market Approval (PMA), or other regulatory filings, as required.
• Liaise with regulatory agencies, such as the FDA, EMA, or other regulatory authorities, to facilitate the review and approval process for new products or product changes.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
• Monitor and interpret changes in regulations and guidelines and communicate potential impact to relevant stakeholders.
• Manage regulatory documentation and maintain regulatory compliance records.
• Participate in regulatory audits and inspections as needed.
• Represent the company in regulatory interactions and meetings with regulatory agencies.

• Bachelor's degree in a scientific or healthcare-related field; advanced degree (e.g., Master's or PhD) preferred.
• Minimum of [X] years of experience in regulatory affairs within the pharmaceutical, medical device, or healthcare industry.
• Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR), ICH guidelines, and other applicable regulations.
• Experience with regulatory submissions, including INDs, NDAs, 510(k)s, PMAs, or other regulatory filings.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and regulatory agencies.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
• Regulatory Affairs Certification (RAC) preferred.

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