Manager, Regulatory Affairs|
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At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful!
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.
The Manager, Regulatory Affairs, leads strategic regulatory direction for product programs and innovative solutions for immunodiagnostic tests. Reporting to the Director, Quality and Regulatory Affairs, this position has responsibility of leading a team through the regulatory submission process, preparing the registrations, pre and post-market, and interactions with the FDA and notified bodies. This position can be remote with up to 15% travel in the future as needed.
Beckman Coulter is seeking a passionate, ambitious leader to join our team. We are on a quest for an individual who thrives working in a sophisticated, fast-paced environment with a strong sense of urgency and a proven track record of flexibility and adaptability.
In this role, you will have the opportunity to:
- Provides day to day management of Regulatory Affairs function for business unit and line support.
- Directs and coordinates activities of experienced Regulatory Affairs professionals.
- Establishes project priorities, allocates resources and workload; thus, has accountability for the performance and results of the regulatory affairs project deliverables.
- Provides technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.
- Oversees preparation and submission of regulatory applications and maintenance of internal regulatory file documentation.
- Develops and implements departmental policy and procedures.
- Provides Regulatory Affairs training/mentoring to other employees.
- Develop and maintain positive relationships with medical device reviewers.
- Establish and support a work environment of continuous improvement.
The essential requirements of the job include:
- Bachelors degree with 9+ years experience or Masters degree with 7+ years experience.
- 2+ years of experience leading projects or staff (staff preferred).
- Strong working knowledge of global medical device regulations and direct experience with the US and EU medical device submissions.
- Thorough understanding of FDA, QSR and ISO standards, regulations, and requirements.
- Strong technical comprehension of medical device products required.
- Proficiency with product development process and design control required.
- Excellent research and analytical skills used in technical writing and editing.
- Proven effectiveness in managing multiple projects.
- Strong organizational leadership, influences others outside of reporting structure.
- Adept presentation skills, network builder, and insightful advisor with ability to develop talent.
It is also a plus if you possess previous experience in:
- In Vitro Diagnostics experience preferred.
- Previous managerial/supervisory experience (2 or more direct reports).
- A RAC Certification preferred.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why well empower you to push the boundaries of whats possible!
When you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation.
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