Regulatory Compliance Specialist

7 days ago


Columbia, Maryland, United States Integra LifeSciences Full time

Join Our Team as a Regulatory Compliance Specialist

 

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Integra LifeSciences. As a Regulatory Compliance Specialist, you will play a critical role in ensuring the efficacy of our critical control programs and maintaining compliance with international standards and regional regulations.

 

This is an exciting opportunity for a seasoned professional to lead cross-functional teams in solving complex problems, implementing process improvements, and developing quality programs that meet regulatory requirements.

 

The ideal candidate will have a minimum of 2 years of experience in a regulated industry, preferably in pharmaceutical, medical device, or biotechnology. A Bachelor's degree or higher is required, with a Master's degree being preferred. The candidate should also possess certifications from reputable organizations such as American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS).

 

Responsibilities

  • Maintain thorough understanding of international standards and regional regulations, including FDA QMSR, ISO 13485, and Regulation 2017/745 (EUMDR)
  • Support launching of new or improved products/processes and facilitate transfer of technology from development to commercialization
  • Facilitate management of changes in device design and manufacturing procedures for commercialized devices
  • Author, edit, and provide guidance on development and implementation of new and updated documents, including validation protocols and reports, product & material specifications, and SOPs
  • Investigate quality events using systematic approach to determine root cause(s) and sequences of events
  • Develop, review, and approve validation documentation for new and existing products, processes, and equipment
  • Prepare monthly and quarterly trending data and analysis reports

 

Requirements

  • Minimum 2 years of experience in regulated industry
  • Bachelor's degree or higher; Master's degree preferred
  • Certifications from ASQ or RAPS; or obtain relevant certification within first year of employment
  • Excellent organizational, communication, and project management skills
  • Demonstrated knowledge of principles of data integrity and coding/scripting proficiency
  • Familiarity with electronic quality management systems and Microsoft suite of applications

 

Estimated Salary: $80,000 - $110,000 per year

 

Integra LifeSciences is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.



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