The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. Will provide subject matter expertise and is responsible for advising and guiding the local organization on regulatory topics. Will also be the primary liaison to Marketing and Sales groups with regard to regulatory requirements for marketing communications and other customer-facing communications. These activities will all be done in full compliance with U.S. and international regulatory requirements.
Prepare FDA submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.
Lead and provide guidance to work teams comprised of senior engineering and marketing personnel with regard to regulatory planning and execution.
Review and analyze product complaints for appropriate domestic and international filings as part of product post-market surveillance.
Conduct post-market surveillance such as literature reviews, clinical study reviews, etc.
Assist with product hazard analyses and recall assessments. Coordinate and lead Field Corrective Action (FCA) and Recall Strategy as needed.
Advise technical, marketing and sales teammates on regulatory requirements (e.g., Design Controls, UDI, Labeling, and Promotion).
Provide guidance and review of product labeling, promotional material, change control and other related product documentation.
Maintain database(s) for the worldwide regulatory status of products.
Maintain regulatory affairs product files to support compliance with requirements and standards.
Assist with regulatory audits from partners and external regulatory agencies
Maintain the company’s Medical Device Listing and Device Establishment registration forms.
Interpret, execute and recommend modification to internal guidelines, work instructions, procedures.
Support the development and implementation of the regulatory department’s policies and procedures and strategic objectives.
Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.
Serves as an internal auditor in order to assure regulatory compliance across all product lines.
Interpret new and existing regulatory requirements as they relate to our sector products and initiate actions to assure compliance to these regulations.
Participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release. Ability to process and close complaints in a timely manner following company procedures.
In collaboration with Regulatory management, lead submission activities for devices in gaining required clearances through the processes of 510(k) s, PMA’s & Health Canada
Assist in various projects as assigned.
Support design verification and validation including usability risk management study planning and report generation.
May be assigned responsibility for consucting on-site supplier audits
Monitor FDA’s databases for product MDR reportings, provide feedback to engineering
EDUCATION and/or EXPERIENCE:
BA/BS degree in engineering or life sciences
At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.
Experience in the preparation of 510(k) submissions
Experience with development and post market support of Class I and II Medical Devices
This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.
Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)
Excellent written and oral communication
Strong project management and organizational skills.
Excellent verbal and written communication skills.