Principal Regulatory Affairs Specialist - EU
Posted on: April 8, 2021
Requisition ID: 47390 Title: Principal Regulatory Affairs
Specialist - EU 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:
- 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
- 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
- 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
- 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:
- 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
- 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. Education/Experience:
- 10 years relevant experience required preferably in a
regulatory affairs role in the life science industry.
- Bachelor's degree required, engineering or science discipline
- 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
- Experience reviewing product labeling and
advertising/promotional material for medical devices.
advertising/promotional material for medical devices. Clinical or
statistical experience preferred. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, age, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.Job
Keywords: Arthrex, Cape Coral , Principal Regulatory Affairs Specialist - EU, Other , Naples, Florida
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