The Regulatory Affairs Manager is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization’s products. Working closely with all departments to develop and execute clinical strategies. Successful execution of clinical studies from initial strategy and development to study closeout, meeting all budget considerations and regulatory compliance. Sets strategy for worldwide governmental approval to introduce new products to market, provides advice on regulatory requirements and prepares worldwide submissions.

ESSENTIAL FUNCTIONS AND BASIC DUTIES
• Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory strategies with leadership team, as necessary, and negotiate submission steps with regulatory bodies.
• Prepare regulatory strategies/plans and worldwide requirements lists. Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
• Provide business and product information to Sr. Director of Quality and Regulatory Affairs to enable development or strategies and requirements and communicate information to leadership team.
• Provide regulatory support for currently marketed products, as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
• Negotiate directly with the FDA or other international agencies, as needed. All significant changes will be reviewed with the Sr. Director of Quality and Regulatory Affairs.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Interact frequently with different members of the organization and outside customers.
• Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
• Review training, promotional and advertising pieces for assigned product lines.
• Provide training and support to other members of the department.
• Manage FDA Establishment Registrations and Listings.
• Support Quality Systems Projects as required.
• Development and implementation of regulatory and clinical strategies, working closely with marketing and regulatory and clinical project teams.
• Overall execution of the company’s clinical programs.
• Leadership of internal clinical project team.
• Recruitment and management of contracted clinical support such as consultants, CRO’s, data management.
• Assistance in the development of all clinical protocols, agreements & budgets, and related study documents.
• Oversight of clinical investigator and site selection.
• Coordination and tracking of all IRB submissions and correspondence.
• Development and maintenance of study trial master files (TMF).
• Preparation of regulatory submissions, (510(k)s, IDE’s, related FDA Correspondence), including the review of content, assembly, and sign-off approval of final documents.
• Assistance to the regulatory guidance regarding product labeling, marketing materials and social media.
• Adheres to all company policies, procedures, and business ethics codes.
• Other duties as assigned.

QUALIFICATIONS
EDUCATION/CERTIFICATION: Bachelor’s Degree required, preferably in Science or Engineering field.

REQUIRED KNOWLEDGE:
• Preferred experience in medical device and software industry
• Ability to provide solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organizational objectives
• Strong problem-solving skills. Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions
• Strong organizational, time management and project management skills
• Clinical, Quality or Regulatory compliance experience
• Complete understanding and wide application of technical or regulatory principles, theories and concepts; general knowledge of other related disciplines
• Demonstrated ability to independently assess risk and develop solutions to critical and difficult problems that are consistent with organizational objectives
• Can conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and transfer data back to NKA, etc.
• Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision; An advanced individual may conduct more complicated studies, as well as contributes to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects
• Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects
• Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used
• Can effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner
• Conduct site monitoring (qualification, initiation, monitoring and close out visits) to insure and document site is trained to follow study procedures per protocol;
• Likewise, can monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations
• Can suggest improvements to departmental procedures relating to GCP monitoring aspects
• Insure essential study documents are properly organized and stored as quality records
• Can conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables
• Writes clear, succinct and detailed clinical study and technical summary reports

EXPERIENCE REQUIRED: Minimum of 8 years’ experience

SKILLS/ABILITIES:
• Effective presentation and interpersonal skills
• Self- motivation
• Excellent verbal/written communication skills
• Project Management and problem-solving skills
• Strong attention to detail and accuracy
• Ability to communicate persuasively in a manner that supports approvals and other key company goals/objectives