Principal Regulatory Affairs Specialist

NORCROSS, GAPosted a month ago

Job summary

• Job post source

  This job is directly from Werfen North America

• Job overview

  The Principal Regulatory Affairs Specialist at Werfen North America manages pre-market regulatory activities to ensure compliance with US FDA, Health Canada, and EU IVD regulations, playing a critical role in product registration and regulatory strategy.

• Responsibilities and impact

  The role involves participating in design teams for product changes, developing global regulatory plans, preparing regulatory submissions such as FDA 510(k), Health Canada licenses, and EU Notified Body submissions, reviewing product labeling and commercial materials for compliance, and supporting new product launches.

• Experience and skills

  Requires a Bachelor's degree preferably in regulatory or science fields, at least 8 years of regulatory experience in the medical device industry, experience with US FDA, Health Canada, and EU regulatory submissions, knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulatory, MDSAP Companion Document, and some exposure to EU MDR or EU IVDR, strong communication and organizational skills, and English fluency.

• Unique job features

  The job includes minimal travel (5-10% domestic and international) and requires balancing multiple projects in a fast-paced environment with minimal supervision.

Company overview

Werfen North America is a leading provider of specialized diagnostic solutions for hospitals and clinical laboratories. They generate revenue by offering a range of products and services, including in vitro diagnostics, clinical chemistry, and patient blood management systems. Founded in 1966, Werfen has a rich history of innovation and expansion, becoming a global player in the diagnostics industry. Their commitment to improving patient care through advanced technology and reliable diagnostics makes them a significant entity in the healthcare sector.

How to land this job

• Tailor your resume to highlight your extensive experience managing pre-market regulatory activities and your knowledge of compliance with US FDA, Health Canada, and EU IVD regulations, as these are central to the Principal Regulatory Affairs Specialist role at Werfen North America.

• Emphasize your skills in preparing and authoring regulatory submissions such as FDA 510(k)s, Health Canada licenses, and EU Notified Body submissions, along with your ability to collaborate cross-functionally with R&D, Marketing, and regulatory agencies.

• Apply through multiple channels, including Werfen North America's corporate careers page and LinkedIn job postings, to maximize your application visibility and chances of being noticed.

• Connect with current regulatory affairs professionals at Werfen North America on LinkedIn to learn more about the division and the role; use ice breakers like commenting on recent regulatory challenges in the medical device industry or expressing interest in Werfen's innovative regulatory strategies.

• Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory submissions,' 'FDA 510(k),' 'Health Canada license,' 'EU Notified Body,' 'labeling review,' and 'regulatory compliance' to ensure it passes automated screening.

• Utilize Jennie Johnson's Power Apply feature to automate tailoring your resume, identify the best application platforms, and find relevant LinkedIn contacts, allowing you to focus your time on preparing for interviews and networking effectively.