Principal Specialist - Regulatory Affairs Division:
Arthrex, Inc. (US01) Location:
INC- Naples FL (US08) 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 Principle Specialist of Regulatory Affairs, North America. The position is based at the Arthrex world headquarters campus 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™.Position Summary:
The Regulatory Affairs Principle is responsible for managing U.S. and Canada product activities related to regulatory submissions and registration for assigned product development teams(s) and working effectively with other country regulatory Specialists to provide submission/registration documentation. The Principle will manage the Regulatory Affairs activities of the assigned product development team(s) by setting priorities and providing guidance and development to direct reports. 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 regulatory plans, and perform other activities that lead to and maintain regulatory approval/clearance/licensure for Arthrex's medical devices.Regulatory Affairs Specialist Duties and Responsibilities
- Plans, assigns and manages regulatory affairs activities for projects within assigned business unit(s) in order to meet deadlines.
- Supervises Regulatory Affairs Specialists, prepares and submits performance reports, sets performance goals, recommends on-the-job training, courses, seminars, etc., and decides on reward and promotion based on performance.
- Develops and/or conducts regulatory training for direct reports.
- Ensures direct reports understand their duties or delegated tasks and monitors productivity, providing constructive feedback and coaching.
- Ensures policies, practices and procedures are understood and followed by direct reports.
- Reports to manager the status of projects and other relevant information on a timely basis.
- Identifies and communicates information to manager which would affect regulatory compliance within the assigned business units.
- Assists in the implementation of team initiatives/plans as specified by manager.
- Independently performs, as well as monitors and guides the work of direct reports, for the below regulatory duties and responsibilities for the assigned business unit(s):
- 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 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 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, guidnces, 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.
- 10 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.
- Clinical or statistical experience preferred.
- Experience supporting change control and new product development projects.
- Advanced knowledge of regulatory framework and regulatory requirements for US and Canada.
- Novice knowledge of human physiology/anatomy and understanding of relevant procedures, practices, and associated medical terminology.
- Intermediate knowledge of orthopedic terminology, surgery Principals, theories, and products.
- Advanced knowledge of current medical device regulations, standards, guidance's and regulatory requirements for medical devices in US and Canada.
- 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.
Come Join the Arthrex Family!Arthrex is a privately held global medical device company that is a leader in new product development and medical education in orthopedics. Arthrex's innovative spirit has pioneered the field of arthroscopy and sports medicine and led to the development of more than 1,000 innovative products and procedures each year. More than 90% of Arthrex's products are manufactured in the United States and exported to more than 100 countries around the world. Arthrex continues to experience unprecedented growth and demand for our products throughout the world.Arthrex's status as a privately-owned, non-listed company enables us to give priority to the needs of our customers for the good of their patients. Arthrex stands unwaveringly committed to its corporate mission, "Helping Surgeons Treat Their Patients Better", by delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.Arthrex headquarters in Naples Florida, where this position will be located, which is approximately 2 miles from pristine white sandy beaches of the Gulf of Mexico and surrounded by state of the art golf courses; upscale shopping districts; numerous outdoor activities such as boating, fishing, kayaking..... click apply for full job details
- Ability to identify and assess business risks for a given Regulatory strategy.
- Ability to plan, evaluate and improve the efficiency of business processes and procedures to enhance speed, quality and output.
- Ability to analyze and resolve non-routine regulatory issues using independent judgment.
- Ability to solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
- Ability to identifies complex problems and review related information to develop and evaluate options and implement solutions.
- Ability to work without appreciable direction.
- Ability to determine objectives and approaches to assignment.
- Ability to develop and mentor others within the department promoting open communication and feedback.
- Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently.
- Must be results orientated.
- Excellent written and oral communication skills.
- Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.
- Proficiency with Microsoft Office, Adobe, etc.