Principal Regulatory Affairs Specialist

CONMED Corporation; Denver (CO); Hybrid; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking an Advanced Surgical Principal Regulatory Affairs Specialist to join their dynamic team. In this hybrid role, you will provide essential regulatory input for new product development and sustaining engineering projects, ensuring compliance with both domestic and international regulations. Your expertise will guide the preparation of regulatory submissions and support ongoing global product registrations. This is an exciting opportunity to make a significant impact in the medical device industry while enjoying a collaborative work environment that values diversity and innovation. If you are passionate about regulatory affairs and eager to contribute to cutting-edge projects, this role is perfect for you.

Benefits

Competitive compensation

Excellent healthcare coverage

Short & long term disability insurance

401K retirement savings plan

Employee Stock Purchase Plan

Tuition assistance

Qualifications

• 5+ years in regulatory, quality, or similar roles.
• Experience with US/EU submission processes and regulatory bodies.

Responsibilities

• Develop and implement regulatory strategies for product registrations.
• Prepare global regulatory files and submissions.
• Collaborate with cross-functional teams on regulatory compliance.

Skills

Regulatory Affairs

Project Management

Communication Skills

Organizational Skills

US/EU Submission Experience

Education

Bachelor’s Degree in Science or Engineering

M.S. in Technical Field or MBA

Tools

Regulatory Submission Software

Job description

The Advanced Surgical Principal Regulatory Affairs Specialist provides regulatory input for new product and sustaining engineering project teams, developing a regulatory strategy for global commercialization of products. The specialist should be capable of identifying both domestic and international regulatory requirements early in product life cycles and coordinating the product registrations to meet company milestones and initiatives.

Key Duties and Responsibilities:

• Represent the Regulatory organization on cross functional teams to develop and implement regulatory strategies and carry out associated team output responsibilities.
• Prepare global regulatory files/submissions for product registration as assigned.
• Review and approve proposed design changes and ECOs to assess regulatory impact.
• Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
• Provide regulatory support for on-going global product registrations as assigned.
• Provide timely review and approval of product labeling for regulatory compliance.
• Participate in all activities associated with product recalls (regulatory agency communications, customer communications, status reports).
• Establish and maintain product recall files.
• May interface with other ConMed business units/affiliates/distributors as assigned.
• Perform other related duties and special projects as required by management.

This will be a hybrid role - 50% onsite in Denver, 50% remote

Minimum Requirements:

• Bachelor’s Degree in science, engineering or related field
• 5+ years experience in a regulatory, quality, or similar position.

Preferred Requirements:

• M.S. in a technical field or MBA preferred
• Additional Regulatory certifications preferred
• Experience within the Medical Device industry preferred

Other Attributes:

• Ability to execute assignments independently as assigned.
• Must possess strong organization skills.
• Must possess strong written and verbal communication skills.
• Demonstrated ability to handle multiple priorities simultaneously.
• US/EU submission experience, including authoring and receiving approvals and interaction with regulated bodies (FDA, Notified Body, etc.).

Physical Requirements:

• Must be able to sit/stand for 8 hours

Disclosure as required by applicable law, the annual salary range for this position is $80,000 - $130,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED’s good faith belief at the time of this posting.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

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

CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.