Director, Regulatory Affairs .
Boston - United States
The Director, Regulatory Affairs will develop and implement effective regulatory and related strategies for the development and commercialization of our clients products. Working closely with leadership, this position is responsible for developing and executing global regulatory affairs strategies, plans and programs for the product development programs and products as well as supporting compliance by interpreting relevant regulations.
The individual will develop, lead and drive approvals of products, taking into account U.S. and OUS regulatory requirements, and provides regulatory expertise and guidance to our clients team of internal stakeholders.
- Provide regulatory expertise and guidance within the collaborative cross-functional teams
- Establish and implement, in collaboration with leadership, global strategic regulatory goals for the development programs and approved products
- Develop content, format, prepare and file regulatory amendments, marketing applications, and other regulatory submissions, and work closely with functional leaders of the company to produce high quality submissions
- Provide strategic input on all key development documents
- Serve as primary contact for Regulatory Agency interactions for the products and establish excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company’s filings.
- Guide the transition to IVDR and UKCA compliance.
- Together with the Sr. Director, Quality Assurance, prepares, coordinates and directs all efforts with FDA interactions, including site visits and audits
- Collaborate with colleagues to support regulatory milestones and goals for product development, as well support regulatory goals for trial design
- Contribute to clinical study design strategy and execution, working in concert and collaboration with research, development and clinical teams
- Interpret scientific and clinical data and leads development of labeling to optimize product potential benefit-risk ratio.
- Anticipate and identify regulatory risks and make recommendations to senior management regarding risk mitigation
- Lead and manage the authoring and coordination of periodic regulatory and/or safety reports for investigational and approved products
- Lead and manage the authoring and coordination of approved product reports to regulatory agencies
- Establish and manage an electronic archive and catalog all submissions to and communications with regulatory agencies
- Liaise with external vendors and support teams to maintain productive relationships, supporting efficient regulatory document preparation and submission activities
- Lead the post-marketing regulatory activities for the company, such as: planning and managing post-approval regulatory submissions, advising marketing and sales management regarding regulatory aspects of product education and promotion activities
- Requires a BA/BS degree, Master’s degree or PhD preferred.
- Required 8 – 10 years related experience within the digital health/medical device industry along with successful experience in development and completion of regulatory submissions such as, 510(k), PMAs, IDEs
- A high level of familiarity and understanding of US and OUS regulations and guidelines, broadly across digital health and diagnostics
- Proven record of leadership and managing regulatory/quality organizations with global responsibility and establishing long term strategic growth initiatives.
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
- Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions.
- Current knowledge of US and international in vitro diagnostic regulations and guidelines.
- Demonstrated success in the development and implementation of facility quality management systems and assuring compliance to all applicable regulations.
- Good working knowledge of applicable regulations and harmonized standards (21CFR820, ISO13485:2016)
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent interpersonal and strong leadership skills; self-motivated and flexible to changing schedules.
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