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Danaher Corporation Regulatory Affairs Associate - Remote in New York, New York

Mammotome associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people as a Regulatory Affairs Associate and be inspired to grow every day!

The Regulatory Affairs Associate is a member of the Global Regulatory Team and participates in global regulatory activities, including regulatory submissions, renewals, license inventory, product and process change assessments, labeling review, and general regulatory documentation requests. The Regulatory Affairs Associate will also participate on New Product Development (NPD) teams to develop and execute a regulatory strategy for new product launches.

Responsibilities we will trust you with:

  • Works with project teams for New Product Development, Sustaining, and cost-saving projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project.

  • Assists Global Partners with the preparation of regulatory submission documentation.

  • Completes reviews of labeling content, product and process changes, and product documentation.

  • Maintains regulatory files in a format consistent with requirements.

  • Analyzes support data for claims verification.

  • Manages facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs]).

  • Develops processes and checklists and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling promotional materials, and assuring the validity of regulatory compliance issues.

  • Collaborates and assists the Global Regulatory Team to support product compliance internationally.

  • Provides regulatory support for internal and external (Regulatory Agency) audits and assists with resolving observations.

  • Evaluates and implements procedures pertaining to corporate and departmental regulatory activities.

Your areas of knowledge and expertise that matter most for this role:

  • Bachelor’s degree preferred in Science/Technology, Mechanical/Biomedical Engineering, or a clinical field.

  • Minimum of 2 years of Regulatory, Clinical or Engineering experience in the food, drug, or device industry required.

  • Understanding of global medical device requirements and practical experience in implementing or managing such activities.

  • Successful track record working in a global matrix/collaborative environment required

  • Professional certifications (i.e., CQM/OA, RAB, RAPS) preferred.

  • The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to juggle multiple responsibilities and deadlines.

  • Team player who can work well across a global organization

Check out our benefits here: www.danaherbenefits.com

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

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When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

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