Medical Writer

Medical Writer

Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer! In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare.

Key Responsibilities:

• Develop and refine strategies and processes for market and customer feedback collection.

• Assist in creating medical device market research protocols and Case Report Forms.

• Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.

• Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.

• Keep relevant procedures up-to-date.

What You'll Do:

• Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746)

• Create market research protocols, deploy questionnaires, and compile technical reports.

• Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)

• Author and update post-market surveillance plans for upcoming and existing medical devices.

• Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.

• Ensure timely creation of deliverables to prevent project delays.

• Develop proactive customer feedback templates and process workflows.

• Communicate roadblocks and escalate issues promptly to stakeholders.

Qualifications:

• Bachelor's degree in clinical research, health sciences, or a related field. Alternatively, 5+ years of experience with medical devices in an Operating Room setting as a CST, CSFA, or RN.

• 0-2 years of experience in the medical device and/or pharmaceutical industry.

Preferred Skills:

• Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance.

• Proficiency in creating PMS plans, PMSRs, or PSURs.

• Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP).

• Understanding of medical device regulations and adverse event reporting.

Disclosure as required by applicable law, the annual salary range for this position is $62,000 to $97,000. 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

Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

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.

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