Danaher Corporation Staff Regulatory Affairs Associate (U.S.A. REMOTE) in New Rochelle, New York
Beckman Coulter Life Sciences’ mission is to empower those seeking answers to life’s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you’ll help drive our vision of accelerating answers—and our commitment to excellence.
Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Are you an accomplished leader who enjoys responding to regulatory agency inquiries while supporting the manufacturing lines when nonconformance exists, to ensure appropriate regulatory assessments and requirements? Then Beckman Coulter is calling you!
We are currently seeking a Staff Regulatory Affairs Associate. Staff Regulatory Affairs is part of the Miami Regulatory Affairs team and will support new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements. Staff Regulatory Affairs is part of the Miami Regulatory Affairs team and will support new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements.
In this role, you will have the opportunity to:
Support complex regulatory strategies for global registration of IVD reagents and systems. Lead EU, Canada, China and International registration activities.
Create high quality technical documentation to comply with IVDR; Create ROW high quality documentation such as technical dossier or STED and liaise with regional regulatory teams to ensure on time submission and clearance.
Liaise and negotiate with regulatory agencies and notified bodies to ensure on time clearance of products in line with regulatory strategy and business commitment.
New Product Development: Actively contribute to development of project plans, deliverables, and timelines. Collaborate with cross functional teams for effective planning and on time execution of regulatory submissions.
Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions.
Apply Danaher Business System (DBS) tools to drive compliant and effective processes; improve capability to support growth.
Assure that there are no significant interruptions to the business due to regulatory or compliance issues.
The ideal candidate will possess the following:
Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean
Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR; China; ROW Global Registrations).
Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDD/IVDR, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations.
Knowledge of design control process requirements and requirements for technical documentation for in vitro diagnostics or medical devices.
Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable.
Selected candidate will meet the following requirements:
Bachelor’s degree in an engineering or life sciences
Minimum of 9 years’ experience in a regulated medical device/ diagnostic industry
Preferred qualifications and attributes for the role include:
Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean.
Critical thinker able to address complex situations and issues.
Acts decisively, holds position and challenges others appropriately.
Manages changing conditions, processes, and approaches; leads organizations through change effectively.
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
Organized and thorough with a high level of initiative, self-motivation and energy.
Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time.
The salary range for this role ($104,000 - $140,000 base) is min-mid range. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
We believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working here can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/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.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .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 firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.