Senior Manager, Regulatory Affairs - Product Development

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 Manager, Regulatory Affairs - Product Development who will manage the operations of a Regulatory Affairs team(s) to ensure strategic regulatory strategy, timely regulatory submission preparation, and the completion of regulatory deliverables throughout the Product Development process in compliance with all applicable regulations and guidance for the commercial distribution of products within the US, EU, and Canada. This position will be responsible for driving the strategic direction (1-3 years) for regulatory activities related to Product Development efforts and play a critical role in regulatory approval efforts with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient and compliant manner. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Develop and implement regulatory strategies for Product Development and continuous improvement projects, ensuring alignment with business objectives and regulatory requirements.
• Lead assigned team(s) in establishing short-term and long-term regulatory goals.
• Oversee the preparation, review, and submission of regulatory filings, including 510(k)s, PMAs, IDEs, and international submissions, as applicable.
• Monitor regulatory landscape for changes and updates that may impact Product Development strategies; proactively assess regulatory risks and develop mitigation plans as needed.
• Provide leadership, guidance, and mentorship to assigned regulatory team(s).
• Foster a collaborative and high-performing team culture focused on achieving regulatory excellence.
• Independently perform, as well as instruct and monitor the work of direct reports for the regulatory duties and responsibilities for the assigned Product Development team(s) listed below:
• 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, and/or clinical study compliance issues.
• Provide project teams with on-going support to resolve any real or perceived regulatory issues.
• Determine and execute the types of regulatory submissions or internal documentation that are required in situations such as proposed design, manufacturing, and 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, testing 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, guidance and/or standards.
• Obtain and distribute updated information regarding domestic or international laws, guidance and/or standards.
• Write or update standard operating procedures, work instructions, or policies, as applicable.
• Contribute to the development and maintenance of quality systems related to Regulatory Affairs, ensuring compliance with applicable regulation and standards.
• Participate in internal or external audits, as required.
• Ensure compliance within functional area and support the compliance objective of the organization as a whole.

Education and Experience:

• Bachelor’s Required. Advanced Degree preferred, preferably in a Science or Engineering discipline
• 3 years management experience required
• 7 years direct experience in Regulatory Affairs in a Medical Device Company required. Orthopedics preferred
• Regulatory experience in U.S. required, Europe (CE) and Canada highly desirable.
• Training in technical aspects of Regulatory Affairs required

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Strong interpersonal and communication skills
• Proficient in Microsoft Office
• Ability to work in fast paced environment
• Advanced written communication skills
• Ability to plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
• Internal and external communication and collaboration skills
• Knowledge and experience in business, supervision, and management
• Ability to lead, develop, and effectively manage employees operating in a department
• Strong interpersonal relationship building and employee coaching/ development skills
• Subject Matter Expert for at least one region or product type
• Advanced understanding of regulatory framework and regulatory requirements for multiple regions
• Comprehensive understanding of orthopedic technical/ engineering/medical terminology
• Knowledge of product lifecycle
• Knowledge of global business/organizational activities
• Work effectively in multinational/multicultural environments

Machine, Tools, and/or Equipment Skills:

MS Office, PC, Databases

Reasoning Ability:

Ability to think critically and propose multiple solutions to solve problems. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.