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 drive regulatory strategies for innovative medical products. This hybrid role offers the opportunity to work both on-site in Denver and remotely, ensuring compliance with domestic and international regulations. You will collaborate with cross-functional teams to prepare regulatory submissions and support ongoing product registrations. With a strong emphasis on organization and communication, this position is perfect for those with a passion for regulatory affairs in the medical device sector. Join a company that values diversity and offers competitive benefits, including healthcare and a robust retirement plan.

Benefits

Competitive compensation

Excellent healthcare coverage

Disability and life insurance

401K retirement plan with matching contributions

Employee Stock Purchase Plan

Tuition assistance for courses

Qualifications

• 5+ years of experience in regulatory, quality, or similar roles.
• Strong knowledge of US/EU submission processes and regulatory bodies.

Responsibilities

• Develop and implement regulatory strategies for product registrations.
• Prepare global regulatory files and submissions for compliance.
• Review product labeling and assess regulatory impacts of design changes.

Skills

Regulatory Affairs

Project Management

Communication Skills

Organizational Skills

Technical Writing

Education

Bachelor's Degree in Science or Engineering

M.S. in a 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.

Salary 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 :

• 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.