Senior Regulatory Affairs Specialist

Overview

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.

Responsibilities

• 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.

Qualifications

Education & Experience

Required :

Preferred :

Knowledge & Skills

Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

$70,800 - $99,120

Additional benefits :

exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.