Regulatory Affairs Medical Writer

📌 Core Information

🔹 Job Title: Regulatory Affairs Medical Writer

🔹 Company: Tyber Medical LLC

🔹 Location: Bethlehem, Pennsylvania, United States

🔹 Job Type: On-site

🔹 Category: ✍️ Copywriting & Content Writing

🔹 Date Posted: Tue Apr 01 2025

🔹 Experience Level: 2-5 years

🔹 Remote Status: On-site

📌 Essential Job Details

🚀 Job Overview

Key aspects of this role include:

• Playing a vital role in post-market surveillance within the regulatory and clinical affairs team
• Coordinating and supporting product safety, efficacy, and regulatory compliance
• Planning and executing Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Plans (CEP), and Periodic Safety Update Reports (PSUR)
• Collaborating effectively with internal teams and regulatory bodies

ASSUMPTION: This role demands strong organizational skills and the ability to work effectively with multidisciplinary teams. A background in regulatory affairs and clinical research is assumed to be crucial.

📋 Key Responsibilities

✅ Maintain and oversee study documentation, including source documents and study regulatory files.

✅ Assist in the preparation and submission of clinical study documentation and support regulatory submissions.

✅ Support PMCF activities to collect data on the safety and effectiveness of medical devices post-market release.

✅ Create and execute Clinical Evaluation Plans and contribute to PSUR/PMSR preparation.

ASSUMPTION: The role is likely to require familiarity with medical device regulations and an understanding of the processes involved in preparing comprehensive regulatory documents.

🎯 Required Qualifications

Education: Bachelor's degree in life sciences, healthcare, or a related field

Experience: 2-3 years in regulatory or clinical affairs within the medical device industry

Required Skills:

• Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, and ISO 13485 regulations
• Excellent organizational and communication skills
• Proficiency in managing multiple tasks and prioritizing effectively

Preferred Skills:

• Experience with medical device writing and clinical trials
• Familiarity with data analysis software and medical terminology

ASSUMPTION: Candidates likely need proficiency with Microsoft Office and other data management tools used in document preparation and regulatory submissions.

💰 Compensation & Benefits

Salary Range: Not specified, but expected to be competitive for similar roles in the medical device industry

Benefits:

• Health insurance coverage
• Retirement savings plan
• Professional development opportunities

Working Hours: 40 hours per week with potential flexibility for urgent deadlines

ASSUMPTION: Compensation and benefits are likely to align with industry standards for a company of Tyber Medical's size and complexity.

📌 Applicant Insights

🔍 Company Context

Industry: Medical Equipment Manufacturing with a focus on rapid product commercialization

Company Size: 121 employees, indicative of an agile, innovative environment

Founded: 2012

Company Description:

• Rapid access to a growing portfolio of orthopedic implants
• Utilizes bioengineered technology like TyPEEK® coatings
• Distributes through private labeling in spine and extremities markets

Company Specialties:

• Spine and extremity/trauma medical devices
• PEEK interbody and antimicrobial technologies
• Private label and OEM partnerships

Company Website: http://www.tybermedical.com

ASSUMPTION: The company's innovative approach and moderate size suggest a dynamic work environment where employees can have a significant impact on product development and commercialization.

📊 Role Analysis

Career Level: Mid-level with opportunities for growth based on performance and initiative

Reporting Structure: May report to a Director of Regulatory Affairs or similar leadership role

Work Arrangement: On-site with potential flexibility for some remote work

Growth Opportunities:

• Pursue leadership roles within regulatory affairs
• Engage in cross-departmental projects for broader exposure
• Develop expertise in emerging medical device technologies

ASSUMPTION: Advancement will depend on individual contributions and alignment with organizational goals, particularly in regulatory innovation and compliance excellence.

🌍 Location & Work Environment

Office Type: Professional office setting within medical equipment manufacturing facilities

Office Location(s): Multiple locations in Bethlehem, Pennsylvania, with additional sites in Florida

Geographic Context:

• Proximity to major medical and research hubs
• Access to a skilled workforce in the medical device sector
• Culturally rich area with a balance of urban and suburban amenities

Work Schedule: Standard business hours with some flexibility required

ASSUMPTION: Given the on-site nature of the role, candidates should be prepared for a collaborative in-person work environment that leverages Bethlehem's strategic location.

💼 Interview & Application Insights

Typical Process:

• Initial application review and screening
• Telephone or video interviews with HR and hiring managers
• On-site interviews or assessments

Key Assessment Areas:

• Regulatory knowledge and problem-solving skills
• Communication clarity, especially in technical contexts
• Cultural fit with Tyber Medical’s values and mission

Application Tips:

• Highlight relevant experience in regulatory and clinical affairs
• Demonstrate strong organizational and collaboration capabilities
• Provide specific examples of past project successes

ATS Keywords: Regulatory Compliance, Clinical Research, Medical Writing, FDA Submissions, ISO Standards

ASSUMPTION: Candidates who strategically align their applications with Tyber Medical’s regulatory focus and technological innovation will stand out in the selection process.

🛠️ Tools & Technologies

• Microsoft Office Suite for document preparation
• Regulatory submission software tools
• Data analysis and management systems specific to the medical device industry

ASSUMPTION: Familiarity with these tools is crucial for efficiency in this role, reflecting industry standards for regulatory affairs work.

👔 Cultural Fit Considerations

Company Values:

• Commitment to innovation and rapid product development
• Focus on quality and compliance in all operations
• Encouragement of teamwork and collaborative decision-making

Work Style:

• Detail-oriented with a focus on thoroughness and accuracy
• Capable of working independently yet valuing teamwork
• Adaptable to the evolving needs of regulatory work

Self-Assessment Questions:

• Do you have a strong understanding of medical device regulations?
• Can you work effectively both independently and in a team?
• Are you able to manage multiple deadlines efficiently?

ASSUMPTION: Candidates who thrive in fast-paced, regulatory-driven environments will find Tyber Medical an ideal fit.

⚠️ Potential Challenges

• Keeping up with dynamic and changing regulatory environments
• Managing multiple concurrent projects with stringent deadlines
• Ensuring compliance amid rapid product innovation
• Liaising effectively between interdisciplinary teams

ASSUMPTION: Candidates should be prepared for a role characterized by high demands in regulatory precision and timely delivery.

📈 Similar Roles Comparison

• Roles in larger firms may have more specialized responsibilities
• Opportunities in start-ups may offer broader exposure and faster career growth
• Compensation and workload may vary significantly based on company size and market focus

ASSUMPTION: Comparing this role with others in the field can help gauge fit based on personal career goals and preferred working environments.

📝 Sample Projects

• Preparation of comprehensive Clinical Evaluation Plans for new medical devices
• Execution of Post-Market Clinical Follow-up studies for existing products
• Submission of regulatory documentation to the FDA and EU regulatory bodies

ASSUMPTION: Involvement in these projects will require close coordination with multiple stakeholders and a deep understanding of regulatory frameworks.

❓ Key Questions to Ask During Interview

• What are the current strategic objectives for the regulatory affairs team?
• How does the company support professional development in regulatory roles?
• What challenges does the team currently face in compliance?
• How does Tyber Medical ensure alignment with evolving industry standards?
• What is the typical career trajectory for a Medical Writer at Tyber Medical?

ASSUMPTION: Preparing informed questions can demonstrate engagement and a proactive approach to aligning individual goals with company objectives.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through the Tyber Medical careers page
• Ensure your resume details experience relevant to the medical device industry
• Prepare a cover letter highlighting your regulatory expertise and commitment to compliance
• Be ready to discuss project management experiences during interviews
• Follow up with a thank you email after any interviews

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.