Regulatory Affairs Senior Principal Specialist

2 weeks ago

GondrecourtleChâteau, Grand Est, United States AVC Medtronic Int'l Trading, Inc Full time

Regulatory Affairs Senior Principal Specialist at AVC Medtronic Int'l Trading, Inc. offers an opportunity to embark on a fulfilling career path characterized by innovation and exploration, while advocating for equitable healthcare access for all.

A Day in the Life The realm of cardiac surgery signifies the final treatment phase for numerous cardiovascular ailments, fostering a close collaboration with cardiac surgeons and the operating room, facilitated by an extensive and diverse product portfolio.

Key Technologies

  • Surgical heart valves
  • Cardiac operating room solutions (e.g., blood management, cannulae)
  • Extracorporeal life support
  • Coronary artery bypass grafting (CABG) solutions

The Regulatory Affairs Senior Principal Specialist is tasked with formulating strategies for global governmental approvals to launch new products, maintaining existing offerings, providing regulatory guidance, preparing international submissions, and negotiating their approval with relevant agencies. This role also encompasses mentoring junior regulatory staff and directing large-scale projects with significant business implications. The position supports global regulatory activities related to cardiac surgery products and therapies, involving cross-functional collaboration and mentorship.

Role and Responsibilities:

  • Define regulatory strategies and oversee submission activities for complex product development and maintenance of approved products.
  • Collaborate with operating unit Regulatory Affairs Specialists and international regulatory teams to deliver regulatory support for new products and modifications to existing offerings.
  • Prepare regulatory submissions (e.g., FDA/Notified Body) for new products and changes, ensuring timely approvals.
  • Review significant product submissions with management and negotiate submission matters with agency representatives.
  • Provide support for marketed products, including reviewing labeling, promotional materials, and documentation for changes requiring governmental approval.
  • Engage directly with FDA/Notified Body and indirectly with international regulatory agencies on various projects/products at the reviewer level.
  • Support regulatory compliance activities, including manufacturing site registration and audits as necessary.
  • Maintain expertise in global regulatory requirements and foster positive relationships with agency personnel.
  • Supply business and product information to international regulatory teams to facilitate strategy development and communicate that information to business units.
  • Offer ongoing support and feedback to product development teams regarding regulatory inquiries.
  • Ensure personal comprehension of all applicable quality policy/system items.
  • Adhere to all work/quality procedures to guarantee compliance with quality systems and high-quality output.
  • May mentor or supervise other Regulatory Affairs Specialists as directed by management.

Must Have: Minimum Requirements

  • Bachelor's degree required
  • Minimum of 10 years of experience in regulatory affairs within the medical device sector
  • Or a minimum of 8 years of medical device regulatory experience with an advanced degree

Nice to Have (Preferred Qualifications):

  • Advanced degree in a scientific field (engineering, physical/biological or health sciences).
  • Expertise in evaluating changes to labeling, design, materials, and manufacturing concerning US and EU requirements.
  • Experience with US submissions, EU MDR, and other global submissions and clearances.
  • Experience conducting advertising and promotion reviews for medical devices.
  • Familiarity with FDA and international regulatory agency requirements.
  • Strong interpersonal skills and ability to work effectively in a team.
  • Understanding of engineering principles, physiology, and medical device usage.
  • Experience with cardiac devices or therapies.
  • Experience collaborating with post-market quality on appropriate actions when issues arise.
  • Ability to manage multiple projects and priorities effectively.
  • Proficient computer skills.
  • Project management capabilities.
  • Excellent oral and written communication skills.

Physical Job Requirements

The above statements are intended to outline the general nature and level of work performed by employees in this position, but they are not an exhaustive list of all responsibilities and skills required.

Benefits & Compensation

AVC Medtronic offers a competitive salary and a flexible benefits package. We are committed to our employees' well-being, recognizing their contributions and allowing them to share in the success they help create. We provide a wide array of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About AVC Medtronic Int'l Trading, Inc.

We are at the forefront of global healthcare technology, tackling the most pressing health challenges facing humanity by seeking innovative solutions. Our mission to alleviate pain, restore health, and extend life unites a dedicated global team.

AVC Medtronic is an equal opportunity employer, committed to providing equal employment opportunities to all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. We also provide reasonable accommodations for qualified individuals with disabilities.

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