Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist collaborates with cross-functional teams and key stakeholders to ensure the completion of assigned tasks. This role involves proactive communication of regulatory changes and fostering trust within the organization. The Specialist maintains active awareness with stakeholders, supports a collaborative workplace environment, and participates in ongoing training to raise awareness about implicit biases.

Responsibilities

• Represent as a Regulatory Affairs lead and collaborate with cross-functional teams and key stakeholders to ensure task completion.
• Proactively communicate the impact of regulatory changes to stakeholders in a timely manner.
• Determine submission and approval requirements for the US and EU regions, and plan to compile, prepare, review, and submit regulatory submissions to the appropriate authorities within specified timeframes (with manager oversight).
• Establish clear communication and proactive follow-up with health authorities to facilitate reviews and ensure submissions are approved within targeted timeframes.
• Collect and organize information per regulatory requirements for preclinical and clinical data, reports, and other applicable documentation.
• Evaluate the integrity of documentation per applicable regulations or deliverable checklists.
• Understand market-specific regulatory filing requirements based on product type and classification.
• Build trust with internal and external stakeholders through clear communication and collaboration.
• Participate in ongoing training and evaluation to raise awareness about implicit biases.
• Read/train on ethics policies and procedures and understand individual roles in compliance.
• Maintain regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirements.

Requirements

• Bachelor’s degree, preferably in a scientific or technical discipline; or Master’s degree in Regulatory Affairs.
• 2 years of experience in regulatory affairs, preferably with working knowledge of product lifecycle management, design controls, risk management, and labeling requirements.

Preferred Qualifications

• Strong communication and project management skills.
• Proactively develops regulatory expertise.
• Proficiency in regulatory tools and software, knowledge of market-specific requirements.

Expected travel: 0-20%. This position is not eligible for employer-visa sponsorship.

Pay

As required by applicable law, the annual salary range for this position is $74,200 - $115,000. The actual compensation may vary based on geographic location, work experience, education, and skill level.

Benefits

• Competitive compensation.
• Excellent healthcare including medical, dental, vision, and prescription coverage.
• Short- and long-term disability plus life insurance — cost fully paid by CONMED.
• Retirement Savings Plan (401K) — CONMED matches contributions dollar for dollar, with the potential for up to 7% per pay period.
• Employee Stock Purchase Plan — allows stock purchases at a discounted price.
• Tuition assistance for undergraduate and graduate-level courses.