Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist plays a essential role in ensuring our products meet all necessary regulatory requirements, allowing us to bring them to market and improve patient outcomes. This position supports the RA activities of the company, ensuring that all production operations comply with the appropriate regulations.

• Support and implement regulatory strategies for new and existing products to ensure compliance with regulatory requirements.
• Assist in development of regulatory strategy and update strategy based on regulatory and company changes.
• Understand and evaluate regulatory history/background of products, disease/therapeutic/diagnostic context in order to assess and support regulatory implications for appropriate submission path.
• Support development, maintenance and updates of regulatory polices and SOPs updating to ensure ongoing compliance.
• Monitor and interpret changes in regulations and communicate potential impact to relevant teams within the company.
• Determine and communicate submission and approval requirements in support of product development projects
• Support the preparation and submission of regulatory filings, including 510(k) submissions, PMAs, and CE mark applications.
• Investigate and evaluate regulatory requirements and processes for new product as well as expanded geographic markets outside of the United States.
• Organize regulatory information and track and control submissions.
• Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
• Participate in and support internal audit processes, inspections and product recalls to ensure compliance with regulations and company policies.
• Maintain all necessary regulatory documentation and ensure it is up-to-date and accurate.
• Maintain annual licenses, registrations and listings.
• Participate in product development meetings to provide regulatory guidance and ensure compliance throughout the development process.
• Participate in regulatory meetings and interactions with regulatory agencies on behalf of the company.
• Provide regulatory support for product labeling, promotional materials, and advertising.
• Train and educate company personnel on relevant regulatory requirements and updates.
• Stay informed about industry trends and changes in regulations to proactively identify potential risks or opportunities for the company.
• Collaborate with external consultants and legal counsel as needed.
• Ensure timely and accurate completion of all regulatory activities to meet product launch timelines.
• Uphold a high standard of ethical conduct and maintain strict confidentiality in all aspects of the job.
• Other duties as assigned.

Education & Experience

Required:

• Bachelor's Degree or an equivalent combination of education and work experience.
• 4 years of medical device regulatory experience, with 2 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class II medical devices.

Preferred:

• Regulatory affairs certification.

Knowledge & Skills

• Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant global regulations related to medical devices.
• Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software.
• Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.
• Ability to establish credibility and build strong collaborative relationships internally and externally.
• Proven leadership and management skills, with effective interpersonal skills to influence, inspire, and engage staff.
• Possess exceptional written and verbal communication skills in preparing multi-stakeholder documents and presentations (e.g., scientific, clinical/medical, regulatory reviewer).
• Strong knowledge in medical device Design Controls and Risk Management.
• Capable of managing multiple projects and complex timelines in a team environment.
• Cross functional collaboration skills needed to foster alignment.
• Excellent influence and impact skills.
• Demonstrated leadership working through complex business needs, finding creative solutions to meet business requirements while maintaining quality and compliance.
• Strong analytical and critical thinking skills.