-
ID
#10482011 -
Job type
Permanent -
Salary
TBD -
Source
Arthrex -
Date
2021-03-02 -
Deadline
2021-05-01
Sr. Regulatory Affairs Specialist
Florida, Naples, 34108 Naples USAPermanent
Vacancy expired!
- 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.
- 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
- Complete understanding and wide application of technical principles, theories and concepts in the field. General knowledge of other related disciplines.
- Advanced knowledge of regulatory framework and regulatory requirements for one region.
- Novice knowledge of human physiology/anatomy and associated medical terminology.
- Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
- Intermediate knowledge of current medical device regulations, standards, guidance s and regulatory requirements for medical devices in region of specialization.
- Intermediate knowledge of 21 CFR 820/ISO 13485.
- Intermediate knowledge of product lifecycle, product development process, design control and change control.
- Novice knowledge of clinical trial strategy and study design, and sponsor reporting requirements
- 5 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. Clinical or statistical experience preferred
Vacancy expired!
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