Regulatory Affairs Senior Consultant

Regulatory Affairs Senior Consultant

POSITION SUMMARY:

The Regulatory Affairs Associates will work with the Regulatory Affairs team providing professional support to medical device and IVD manufacturers selling internationally.

MedEnvoy is looking to hire for a full-time permanent position, this is not a contracted position.

MAJOR DUTIES AND RESPONSIBILITIES:

1. Provide high-quality subject matter expertise and interpretations on applicable medical device regulations.

2. Formulate regulatory strategies and roadmaps.

3. Assist with the compilation and conduct regulatory reviews of Technical Documentation files.

4. Day-to-day activities associated with Post Market Surveillance (PMS) for our customer base:

• Reviewing and processing of serious incidents related of medical devices of customers.
• Supervision of field safety corrective actions performed by clients.
• Communication with competent authorities and clients.
• Addressing post market surveillance queries from Competent Authorities
• Managing post market surveillance surveys of clients to ensure compliance with applicable regulatory authorities

5. Support our customer base with respect to updating Technical Documentation files and associated documentation, e.g. risk analysis, clinical evaluation report, in addition to developing and updating Post Market Surveillance reporting.

6. Assist in addressing and responding to deficiencies.

7. Contribute to the development and design of internal processes, product classification and solutions to bring to the market.

8. Assist with the company's Quality Management System to ensure compliance with ISO 13485, EU 2017/745, EU 2017/746 and other country specific regulations.

9. Contribute to the development of external communications and provide internal/external training modules on quality and regulatory.

10. Perform peer reviews of colleagues' work output to ensure high-quality and consistent work.

11. Effectively manage workflows to meet business goals, needs, and objectives.

QUALIFICATIONS:

• Bachelor's degree or equivalent in a Scientific, Engineering, or similar discipline.
• 7 or more years of experience in Regulatory Affairs in medical device industry, including EU technical development files and post-market surveillance. Priority given if at a Leadership or Managerial Level.
• A demonstrated knowledge and understanding of global medical device regulations, including but not limited to EU, Switzerland and UK.
• Knowledge of ISO 13485 and 21 CFR Part 820.
• Knowledge of quality assurance processes (CAPA, complaint handling) is preferred.
• Client-facing experience.
• Highly proficient in spoken and written English, proficiency in other languages is a plus.
• Excellent analytical and writing skills.
• Effective interpersonal communication skills – both written and oral.
• Committed attention to detail.
• Proficiency with Microsoft Office Suite, Adobe Acrobat, and Google Sheets.
• Ability to prioritize tasks, deadline-oriented, and good organizational, problem-solving, and follow-up skills.

Benefits

• 20 days PTO
• Unlimited Sick Leave
• Eligibility for bonus compensation plan
• 401K
• Insurance Stipend or Insurance Plan
• Short Term Disability coverage
• Work-life balance- remote and flexible scheduling

Job Type: Full-time

Pay: From $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 7 years

Application Question(s):

• What motivates you to work as a Senior Consultant for MedEnvoy?

Education:

• Bachelor's (Required)

Experience:

• Tech File Review and Post-Market Surveillance: 5 years (Required)
• Regulatory Affairs: 7 years (Required)
• International medical device and IVD registrations: 5 years (Required)
• Medical Device and/or IVD: 7 years (Required)
• MDR/IVDR Technical File submissions for Notified Body review: 5 years (Required)
• RA consulting: 5 years (Required)

Work Location: Remote