Manager of Regulatory Affairs

Job Purpose

The Manager of Regulatory Affairs is responsible for the daily activities of the company's Quality Assurance and Regulatory Affairs functions. This position ensures continued compliance with applicable regulatory requirements and the company's Quality Management System while providing cross-functional leadership for product development, manufacturing, supplier quality, regulatory compliance, and quality improvement activities.

• Duties and Responsibilities Ensures, with support from the VP of RAQA, that products are in compliance with domestic and international regulations including, but not limited to, 21 CFR Part 820, EN/ISO 13485, the European Medical Device Directive, European Medical Device Regulation, and the Canadian Medical Device regulations.
• Actively participates and assists in the development of new products and processes. Provides input relative to design and testing to ensure compliance for registration and product approval.
• Works with Product Development on design Verification and Validation activities.
• Ensure that the appropriate biological testing was conducted for the type of device or that a biological risk assessment has been conducted.
• Actively participates in risk management activities such as DFMEAs or PFMEAs. Ensuring the consistent application of risks are made across similar product lines.
• Participates in the final review and release of new devices into inventory.
• Reviews new designs for adoption into the current sterilization validations. Will work with Sterilization group for products that will require new sterilization validation.
• Participates in supplier selection, risk assessment and qualification. Assists with records of supplier quality performance and summary reports to management.
• Works with Product Development to identify device critical features and Control Plans for new products.
• Ensures the Material Review Board and its activities related to disposition of non-conforming product are addressed with appropriate corrections or corrective actions to address the root cause.
• Assist in managing the quality engineering/quality control functions to ensure that both departmental areas are adequately staffed and have the proper tools and resources to capably perform their jobs.
• Applies knowledge of Quality Control to maximize inspection efficiencies, solves problems, generates cost saving, improves quality and provides new product support.
• Work with Manufacturing and Manufacturing Engineering to develop Statistical Quality Controls methods to monitor manufacturing production to develop efficiencies based on product non-conformances.
• Assists with the preparation of domestic product submissions including 510(k) and Technical Files, as necessary.
• Maintains product registration files for domestic and international.
• Participates in the development of operating procedures and ensures that all company employees follow written operating procedures and specifications.
• Maintains and issues, as appropriate, corporate and external policies, standards and guidance documents.
• Ensures that complaints, adverse events and product field actions are handled and that reports of adverse events are submitted to appropriate agencies in accordance with established procedure and domestic and international regulations and standards.
• Ensures the proper registration, listing, licensing, notification and approval information is accurately submitted to regulatory authorities or authorized representatives.
• Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Implants Cards, Sales/Marketing Literature, Web-site information and Booth Graphics to ensure adherence to applicable regulations and standards.
• Assists in assuring labeling compliance with U.S. and international regulations and requirements.
• Maintains the companies' GUDID accounts, ensuring that the GUDID database is updated timely as products are launched and discontinued.
• Maintains international regulatory databases, ensuring that all information is up to date and accurate.
• Maintains FDA device listings and Product codes as well as maintaining current Certificates to Foreign Government.
• When necessary, assist with product recall activities in accordance with established procedure and domestic and international requirements.
• Collects information to assist in, or report, Adverse Events and Malfunctions as well as follow-up reports in a timely manner to all affected countries.
• Communicates with consulates, embassies and international distributors via phone, e-mail and fax. Resolves communication and translation issues quickly through creative channels.
• Performs or assists with domestic or international product registrations.
• Ensure training requirements are established and maintained based on applicable regulatory, quality system, job-specific, and organizational requirements.
• Other duties as may be assigned.

• Qualifications Associate degree required, Bachelor’s degree preferred.
• Five to Seven years of QA/RA experience with medical device company or related field.
• Excellent written and verbal communications, and interpersonal skills
• Ability to analyze and interpret quality data
• Willingness to work flexible schedule and travel occasionally
• Integrity, honest, and trustworthy
• Ability to participate in and facilitate group meetings

• Physical requirementsPhysical - Requires walking/standing approximately 5% of time; sitting approximately 95% of time; lifting up to 50 lbs. approximately 15% of time; stooping, forward bending and crouching approximately 5% of time.
• Environmental - Requires capability of performing essential job functions in an office/lab environment with climate-control and good lighting.
• Manual Dexterity - Requires use of hands and arms to operate telephones, facsimile machines, computers and other general office equipment, lab equipment, and to record written information and maintain files.
• Audible - Requires the ability to verbally communicate with supervisor and co-workers in person and via telephone.