Senior RA Specialist

Job Opportunity

This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Job Responsibilities:

• Develop worldwide strategies for regulatory approval of new and modified products.
• Prepare robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.
• Coordinate, comply, and submit regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
• Represent Regulatory Affairs on cross-functional product development and manufacturing support teams.
• Guide teams to provide content for submissions and participate in design reviews as needed.
• Maintain annual licenses, registrations, and list information. Assists with compliance with product post-marketing approval requirements.
• Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
• Review, edit, and approve Advertising and Promotional materials.
• Act as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary details.
• Maintain ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems.
• Ensure that details of any new or modified regulations are distributed to appropriate personnel.
• Support the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
• Interface directly with regulatory agencies as needed.
• Conduct reviews of product and manufacturing changes for compliance with applicable regulations.
• Communicate with and maintain productive, constructive relationships with external customers as required – regulatory authorities, Notified Bodies, in-country affiliates and/or distributors.
• Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

Required Qualifications:

• Bachelor’s Degree in a related field OR an equivalent combination of education and work experience
• 3-4 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Strong organizational and follow-up skills, as well as attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Preferred Qualifications:

• Minimum of 5 years of experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus
• Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
• Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Experience with word processing, spreadsheet and presentation graphic software packages is required.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Ability to identify, solve problems, and work independently with little oversight.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner.