Senior Manager, Regulatory Affairs|
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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 Senior 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 the primary responsibility of leading and advising a team through the regulatory submission process, preparing the registrations, and interaction with the FDA and notified bodies. In this leadership role, you will help craft a regulatory strategy for diagnostic (Dx) products to improve clinical outcomes.
This position is part of the Regulatory Affairs team and will be hybrid in Chaska, MN but a fully remote role may be considered. Anticipated future travel is up to 25% travel as needed for the role. At Beckman Coulter Diagnostics, our vision is to advance healthcare for every person! It is the group's intention to lead all elements of the quality system by driving improvement, sustainment, and management of the global quality systems and deliver harmonized, consistent, and compliant processes to Beckman Coulter sites globally.
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:
- Provide leadership to staff (3) including Regulatory Affairs Managers and professional associates focused on product submission/registration activities.
- Develop departmental plans and is accountable for the performance and results of the regulatory affairs department.
- Assess regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to US FDA and other regulatory agencies.
- Identify and communicate potential risks and mitigations associated with regulatory strategies to cross-functional business teams, senior leadership, and other stakeholders.
- Represent Beckman in interactions/negotiations with U.S. and other global regulatory agencies and enables, coaches, and empowers staff to effectively interact and negotiate with regulators.
- Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S., Canada, EU, and China.
- Find opportunities for continuous improvement that have significant impact (cost, cycle time, quality, etc.) and assist in developing or carrying out an implementation plan.
- Manage the preparation and filing of pre-market submissions and Technical Files.
- Oversee the regulatory review of labels, labeling, and promotional materials.
- Hire and develop staff to meet business needs, creating pipeline of talented professionals for progressively challenging and responsible roles.
- Designs and implements training on regulatory issues for functional staff and for cross-functional groups.
The essential requirements of the job include:
- Bachelors Degree in Science, Engineering or Regulatory Affairs and 14+ years of experience, or Masters/Doctoral degree and 12+ years of experience in a regulated medical device industry working with cross-functional product development teams.
- 4+ years mentoring and managing direct staff.
- 3+ years of experience with In Vitro Diagnostics.
- Demonstrated deep RA strategy development experience
- Subject Matter Expert on Pre- and Post-market medical device regulations, requirements, and submissions, De Novo submissions, PMA, 510(k), and 21CFR820.30.
It would be a plus if you also possess previous experience in:
- RAC Certification
- Global/International submissions and registrations experience
- Project management abilities
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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