RA Director NA, Compliance & Strategic Programs

Diasorin•Austin, TX

About The Position

The RA Director NA, Compliance & Strategic Programs will be responsible for directing Regulatory related activities for software/hardware of DiaSorin immuno and molecular units. This leadership role will ensure full support in identifying regulatory strategies to be aligned with company goals and the evolving regulatory environment in the healthcare industry. The Director SD&I Compliance & Strategic Projects Regulatory Affairs, North America will also collaborate with key cross-functional teams including R&D, Legal, Marketing, Clinical Affairs, and Operations to assure RA Compliance in submission process for North American market, including the United States and Canada.

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.