Pre-Market Regulatory Affairs Manager

Department: Regulatory Affairs
Reports to: Global Director Regulatory Affairs
FLSA Status: Exempt

POSITION SUMMARY

The Regulatory Affairs Manager will be a working manager, responsible for determining regulatory requirements that affect the company and its products and for the process of preparing submissions to US and international regulatory agencies. The Regulatory Affairs Manager is the liaison for communication with regulatory agencies and regulatory agency inspections. This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities.

Regulatory Submissions

Responsible for the preparation and submission of all global regulatory documents. This includes product approval submissions and licenses required by Canada, the European Union, and the Unites States. Maintenance of Technical Documentation, Declarations of Conformity, MDD product lists, Clinical Evaluation Reports and Canadian licenses. Review protocols and reports to support regulatory submissions. As required, responds to requests for regulatory information from distributors, other manufacturers, and device users. Maintains regulatory databases and records. Oversee the electronic submission publishing activities conducted by an external vendor for International registrations. Responsible for establishing and maintaining the regulatory submission archive.

Regulatory Support

Provide input and guidance to product development teams on regulatory requirements and regulatory strategies. Serve as the Regulatory Affairs representative on program teams and cross-functional sub-teams. Responsible for establishing and maintaining the regulatory submission archive. Provide feedback and execute regulatory filing strategies and submission types. Work with RA Global Director to develop regulatory and compliance operating procedures and policies. Perform regulatory assessment of device modifications. Support the coordination of FDA and regulatory agency meetings to determine regulatory strategies for new products and new clinical applications.

International Regulatory Affairs

Determine international regulatory requirements and submit international regulatory registration documents. Preparation of export certificates. Interact with representatives of domestic and international partners and international regulatory authorities to discuss regulatory issues and submission requirements. Keep current with global regulatory trends and emerging requirements.

Regulatory Liaison

Liaison with regulatory agencies as a representative of the Regulatory Affairs department. Provide regulatory review of technical reports and protocols, labeling and advertising, and engineering change orders. Participate in regulatory inspections and audits. Ensure proper communication of regulatory strategies and issues to executive management and affected departments. Provide training in regulatory requirements to company personnel. Keep current on changing global regulations, product line and customer needs. Research regulatory issues and providing guidance and advice to colleagues. Actively support CAPA’s as they apply to Regulatory Affairs.

Labeling

Ensure compliance with labeling regulations. Work with internal subject matter experts to determine the requirements for product labeling, control the product labeling process Manage the process for the preparation and translation of labels and instructions for use. Obtain and maintain GTIN numbers and GUDID Registrations.

Collaboration & Integration

Build working relationships with cross functional teams including Development, Supply Chain, Manufacturing Operations, Commercial Operations, Quality Assurance, Clinical Education and Marketing to ensure process solutions are compliant, efficient, and adaptable to the business. Lead new business projects (external manufacturers, distributed products) to ensure compliant and effective data / knowledge transfer. Support Regulatory and Field Actions Committees, FDA inspections, Health Authority Inspections, and other types of regulatory agency inspections/audits.

Other duties and projects, as assigned.

MANAGEMENT/LEADERSHIP RESPONSIBILITIES

The Pre-Market Regulatory Affairs Manager will manage and provide leadership to regulatory specialists at varying levels. Some aspects of the responsibilities include but are not limited to ensuring appropriate resource allocations, employee development, establishing clear goals for each individual that ties to the company goals, performance review completion and budgeting. The Pre-Market Regulatory Affairs Manager will provide input, guidance and the necessary tools to the regulatory specialists to ensure project success.

Requirements
QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or abilities required.

EDUCATION AND EXPERIENCE

Bachelor’s Degree in Engineering or Science; 6-12 years of experience in Regulatory Affairs with strong medical device product development, preferably with active medical devices. Knowledge of electrical safety standards and principles of software validation. Also, knowledge in Investigations, Root Cause Analysis, Statistical Analysis, Risk Management, Design Control, Process Validation, FMEA/Risk Assessment, and ISO/QSR; RAC certification preferred.

ATTRIBUTES & CRITICAL COMPETENCIES

  1. Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
  2. Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
  3. Able to present to multiple levels and departments within the organization; Strong interdependent partnering skills, interpersonal communication, influencing skills without direct line authority.
  4. Able to support change initiatives, develop strong effective relationships with key resources and decision makers.
  5. Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations
  6. Able to lead an organization through continuous improvement and change; Competency in understanding system functionality in relation to process requirements.
  7. Able to maintain up-to-date knowledge and ensure proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.

EMPLOYMENT WITH APYX MEDICAL

All employment with Apyx Medical is considered employment-at-will.  Employment-at-will means that either party can sever the employment at any time for any reason.  Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole absolute discretion.

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