The Senior Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation, submission, and tracking of regulatory documentation. This position requires strong collaboration, communication, and analytical skills to support product development, market access, and post-market activities in alignment with global regulatory requirements.
** This is a hybrid role in Denver, Colorado requiring 2-3 days in office. **
Responsibilities:
- Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Collaborate with quality, clinical, legal, commercial, and reimbursement teams to align regulatory strategies.
- Identify regulatory submission and approval requirements, and develop a comprehensive plan to compile, prepare, review, and submit documentation to authorities in the US and EU within established timelines. Track and report the status of regulatory actions and submissions to internal stakeholders.
- Understand and apply regulatory requirements for product classification, market access, and advertising/promotion.
- Participate in inspections, audits, and post-audit corrective actions.
- Use appropriate sources to justify product classification and regulatory strategies.
- Train others in the use of regulatory systems and tools.
- Raise issues, roadblocks, and grievances through appropriate channels.
- Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.
- Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.
- Stay current with health authority guidelines and perform regulatory intelligence tasks.
Qualifications:
- Bachelor's degree, preferably in scientific or technical discipline.
- 5+ years of Regulatory Affairs experience preferably in medical device industry.
Preferred Skills:
- Regulatory working knowledge of product lifecycle management, design controls, risk management and labeling requirements
- Familiarity with FDA, EU MDR, and other relevant international regulatory standards and regulations.
- Authored regulatory submissions, such as 510ks, EU MDR technical documentation, and/or Pre-Sub notifications.
This position is not eligible for employer based sponsorship.
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.
This job posting is anticipated to close on September 15, 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.