SalaryUSD TBD TBD
Requisition ID: 47390 Title: Principal Regulatory Affairs Specialist Division: Arthrex, Inc. (US01) Location: Naples, FL Main Objective: Responsible for managing specific aspects of the Arthrex Regulatory Affairs program with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts. In coordination with management of Regulatory Affairs, this role will develop regulatory strategy, execute the regulatory plan, and perform other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex s medical devices. Essential Duties and Responsibilities:
May evaluate the risk of proposed regulatory strategies and offer solutions as applicable. Advise project teams on premarket regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues. Provide project teams with on-going support to resolve any real or perceived regulatory issues. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. Coordinate, prepare, write, submit and/or review regulatory submissions for projects in accordance with established product launch or other applicable timelines. Coordinate efforts with regional counterparts associated with the preparation of international regulatory documents or submissions. Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. Review and approve design control documentation, engineering change requests, manufacturing and labeling changes, and other applicable requests for adherence to global regulatory compliance. Review and approve product advertising/promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies. Review or edit regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability. Communicate with regulatory agencies with or without direction regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. Establish, develop and maintain positive relationships with regulatory agency personnel. Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. Maintain current knowledge base of existing and emerging regulations, standards, and/or guidance documents. Explain regulations, guidance s, policies, and/or procedures to stakeholders, as applicable. Review clinical protocols to ensure collection of data is sufficient for regulatory submissions. Recommend changes to company procedures in response to changes in regulations, guidance s and/or standards. Obtain and distribute updated information regarding domestic or international laws, guidance s and/or standards. Write or update standard operating procedures, work instructions, or policies. Participate in internal or external audits, as required. May develop or conduct employee regulatory training Additional Duties and Responsibilities- May coach, review and delegate work to lower level professionals. Problem Solving- Develops technical solutions to complex problems which require the regular use of ingenuity and creativity Discretion/Latitude- Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results. Impact- Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Liaison- Represents organization as prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations. Knowledge:
- Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
- Applies extensive technical expertise and has full knowledge of other related disciplines.
- Advanced knowledge of regulatory framework and regulatory requirements for multiple regions.
- Novice knowledge of human physiology/anatomy and medical terminology.
- Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
- Advanced knowledge of current medical device regulations, standards, guidance s and regulatory requirements for medical devices in region of specialization
- Advanced knowledge of 21 CFR 820/ISO 13485.
- Advanced knowledge of product lifecycle, product development process, design control and change control.
- Intermediate knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
- 10 years relevant experience required preferably in a regulatory affairs role in the life science industry.
- Bachelor s degree required, engineering or science discipline preferred.
- Advanced degree preferred.
- Orthopedic medical device experience preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area.
- Experience reviewing product labeling and advertising/promotional material for medical devices. advertising/promotional material for medical devices. Clinical or statistical experience preferred.