Director of Regulatory Affairs
Brisbane, CA, USA | Cutera, Inc.
Job Description:81 people have viewed this job
The individual is responsible for activities to lead and maintain global regulatory approval to market devices.Additionally, the individual is responsible for assessment of device changes for regulatory implications and develop strategies for submissions and maintenance of documentation within the framework of regulatory requirements in an efficient manner.
Duties and Responsibilities:
Develop strategies for regulatory approval of medical devices.
Responsible for preparation and submission of 510(k)s, IDEs, and Technical Files (CE Mark) to support the multiple product lines.
Identifies, plans and develops strategies to meet the regulatory requirements that permit the successful registration of products worldwide based upon business needs.
Identifies, develops, and implements innovative process initiatives that promote efficiency of worldwide registrations.
Organizes project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined.
Will participate in new business development activities as needed. This position will require interaction with the U.S. FDA and other regulatory authorities around the world and will participate in audits and other applicable activities.
Coordinate submission activities for a variety of device regulatory approvals including: US pre-market approvals, international design dossiers and/or technical files, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.
Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization.
Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
Participate in training and mentoring of staff.
Coordinate IFU development activities.
Participate in department systems development initiatives.
Prepare deliverables for Management Reviews.
Develop innovative means to comply with regulatory requirements in an efficient manner.
Maintain compliance with FDA, GMP/QSR, Manufacturing process/Work Instructions and ISO 13485.
Other duties as assigned.
Bachelor’s Degree in scientific field is required or equivalent experience. A Master’s degree is preferred
Eight-Plus years of related regulatory experience in the medical device industry, particularly 510(K) and Health Canada and other international locations
High level of attention to details and organization skills.
Effective verbal and written communication skills.
Demonstrated aptitude for preparing and submitting 510(k)'s in addition to preparation of EU Design Dossiers and experience with the GHTF.
Prior interaction with the FDA and other worldwide agencies is required.
Experience working with cross-functional teams is required in addition to previous aptitude thriving within a complex regulatory environment.
Ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms.
Thorough knowledge and understanding of FDA’s QSRs, ISO 13485:2016 and MDR (EU 2017/745) and other national/international standards.
Hands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
Ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously. Previous experience mentoring and training staff is Preferred.
Proficient in use of MSWord, MSExcel, PowerPoint is required.
Good writing skills and formatting skills.
Ability to work well under pressure and handle multiple projects and meet deadlines.
Ability to read and understand regulations, standards and procedures.
Good leadership, analytical and interpersonal skills.
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