Regulatory affair Specialist

As a Regulatory Affairs Specialist you will be responsible for ensuring compliance with regulatory requirements related to the development approval and marketing of pharmaceutical medical device or other healthcare products. You will work closely with cross-functional teams to navigate the complex regulatory landscape and to ensure that products meet all applicable regulations and standards.

Responsibilities:

• 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.

Qualifications:

• 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.