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Danaher Corporation Director Counsel, Regulatory / Medical Devices in San Jose, California

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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Principal duties and responsibilities:

Act as a strategic partner to executive leadership on legal and compliance issues related to Medical Device law, regulation and policy, and related government policy and implementation. Provide counsel on issues related to the US Food, Drug and Cosmetic Act, medical device regulations and policies, including those relating to recalls, promotion and advertising, clinical studies, medical device reporting, corrections and removals, product approvals, inspections, and FDA’s quality system regulations. Provide legal oversight for the quality management system and related activities

Assist the management and business clients in meeting commercial goals with appropriate legal and business oversight. Supervise the external regulatory and enforcement environment to identify risks to the operating companies and their customer relationships, day-to-day counseling, and training of operating companies’ functional groups. Update management on regulatory developments and communicate new developments to the affected business clients. Partner with the Regulatory Affairs/Quality Assurance teams to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, tools, and training materials. Provide litigation support (directly or in conjunction with outside counsel) related to regulatory matters. Support the operating companies, as requested, in interactions with regulatory authorities. Provide legal support for compliance investigations involving issues with the regulatory authorities.

Advise the Company on marketing and promotional matters. Partner with product and marketing teams on relevant marketing and promotional matters.

Assist the Company in obtaining the regulatory authority clearance and approval to market products. Assist in aligning with regulatory authority post-market requirements. Provide advice and counsel on various sales and marketing as well as other materials for dissemination relating to the Company and its potential products, as well as respond to requests from the RA/QA teams for reviewing product labeling and liability questions. Lead outside regulatory counsel.

Education, experience, and required skills:

  • Bachelor’s degree or equivalent, and a J.D. degree from an accredited U.S. law school.

  • Licensed and admitted to practice law in good standing in at least one U.S. state

  • At least 7 years of experience in private practice, in-house counsel and/or government (FDA);

  • Experience in advising on and working knowledge of healthcare and medical device regulations, including FDA, Anti-Kickback/Anti-Fraud compliance, STARK laws, HIPAA, advertising and promotional labeling, clinical trials (both investigator-initiated and vendor initiated), and other similar laws and regulations applicable to therapeutic medical devices needed.

  • Expertise in FDA medical device laws and regulations, Investigational Device Exemptions, Investigational Review Boards, Marketing/Advertising/Promotion Regulations.

  • Licensed to practice law.

  • Strong management skills with the ability to lead cohesive and productive teams. Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.

  • Excellent oral and written communication skills.

  • General understanding of principles relating to medical device regulations of other countries would be an asset.

  • Prior experience in a medical device company would be a big plus.

    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 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 we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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