Senior Specialist, Regulatory Affairs at Arthrex in Naples, FL
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist of Regulatory Affairs. The Regulatory Affairs Senior Specialist is responsible for managing product activities related to regulatory submissions and registration for assigned product development initiatives. This position will play a critical role in regulatory approval efforts by developing regulatory strategy, executing regulatory plans, and performing other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices. This position can be remote or based out of the Arthrex headquarters in Naples, Florida. Relocation assistance may be available along with Arthrex's exceptional employee benefits and work culture. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better(TM). Duties and
Responsibilities:
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. Evaluate the risk of proposed regulatory strategies and offer solutions as applicable. Advise project teams on pre-market 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 promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies. 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. 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, 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, guidances and/or standards. Obtain and distribute updated information regarding domestic or international laws, guidances and/or standards. Write or update standard operating procedures, work instructions, or policies. Requirements:
5 years' experience in a regulatory affairs role in the medical device industry required, orthopedics preferred. Bachelor's degree required, engineering or related science discipline preferred. Advanced degree 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. Experience supporting change control and new product development projects.
Salary Range:
$80K -- $100K
Minimum Qualification
Legal & Regulatory, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
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. Evaluate the risk of proposed regulatory strategies and offer solutions as applicable. Advise project teams on pre-market 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 promotional materials, labeling, and/or test methods for compliance with applicable regulations and policies. 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. 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, 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, guidances and/or standards. Obtain and distribute updated information regarding domestic or international laws, guidances and/or standards. Write or update standard operating procedures, work instructions, or policies. Requirements:
5 years' experience in a regulatory affairs role in the medical device industry required, orthopedics preferred. Bachelor's degree required, engineering or related science discipline preferred. Advanced degree 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. Experience supporting change control and new product development projects.
Salary Range:
$80K -- $100K
Minimum Qualification
Legal & Regulatory, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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