Compliance Director Jobs

About The Position

Requirements

• Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs.
• Minimum of 5 years of experience in regulatory affairs.
• Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions.
• In-depth knowledge of the regulatory landscape in North America.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership.
• High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management.
• Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
• Ability to travel as required for business needs.
• Strong proficiency in regulatory compliance tools, document management systems, and project management software.
• Demonstrated ability to drive results in a fast-paced, high-growth environment.

Nice To Haves

• Certification in Regulatory Affairs (e.g., RAC) is a plus.

Responsibilities

• Identifying new regulatory requirements and giving guidance for the local implementation ensuring the application of pertinent DiaSorin regulatory procedures
• Ensuring regulatory compliance of strategic projects
• Ensuring compliance with various regulation requirements and/or programs such as FDA, Health Canada and state agencies.
• Interacts with regulatory agencies and ensures compliance with all applicable regulations including ISO, Local, State, and Federal requirements, where applicable.
• Support RA team in develop and implement regulatory strategies for the products in North America, ensuring timely market access for all new products and continued compliance for existing products.
• Support the team, fostering a high-performance culture and a deep understanding of regulatory requirements and industry standards.
• Identifying potential risks and opportunities, and ensuring alignment with global corporate objectives.
• Stay abreast of industry trends and regulatory changes impacting product approval processes, quality standards, and market access requirements in the U.S. and Canada.
• In conjunction with RA team assure Compliance in submissions and approvals for new Immuno and Molecular Diagnostics products with the FDA, Health Canada, and other relevant regulatory bodies.
• Review regulatory filings, including pre Submissions, 510(k) premarket notifications, PMA (Premarket Approval) applications, and other relevant filings as required by regulatory authorities.
• Partner with RA team in the preparation and submission of regulatory documents, ensuring that all submissions meet regulatory requirements and are completed on time.
• Establish and maintain relationships with key regulatory agencies to facilitate approval processes and support post-market surveillance.
• Partner with the R&D, Quality Assurance, Clinical Affairs, and Operations teams to ensure regulatory requirements are fully understood and integrated into product development processes.
• Support risk management efforts related to regulatory compliance, ensuring that product-related issues are identified early, mitigated, and resolved in a timely manner.
• Address regulatory challenges, providing solutions to support business continuity, and managing any regulatory hurdles that may arise during product lifecycle management.

Benefits

• competitive rewards package focused on your overall well-being
• comprehensive plan of health benefits
• retirement and financial wellbeing
• time off programs
• wellbeing support and perks
• annual incentive program