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 Denver. This hybrid role involves developing regulatory strategies for global product commercialization, ensuring compliance with domestic and international regulations. The ideal candidate will have a strong background in regulatory affairs, quality assurance, and project management, with the ability to work collaboratively across teams. If you are passionate about making a difference in the medical device industry and thrive in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• 5+ years experience in regulatory affairs or quality roles.
• Strong communication and organizational skills are essential.

Responsibilities

• Develop and implement regulatory strategies for product registrations.
• Prepare global regulatory files and submissions for product registration.

Skills

Regulatory Affairs

Quality Assurance

Project Management

Communication Skills

Organizational Skills

Education

Bachelor’s Degree in Science or Engineering

M.S. in a Technical Field or MBA

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 based in Denver, CO. You will be required to come onsite on a weekly basis.

• 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.

Colorado residents: In any materials you submit, you may redact or remove age identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Legal
• Industries
• Medical Equipment Manufacturing