£140.6k - 196.9k per year
about 1 year ago
If you’re looking for progression, the chance to work for a market leader in their field, or fancy changing things up in your career, then why not jump at this opportunity?
If you have the know how when it comes to Regulatory Affairs, the FDA, and IVDs, then this is the opportunity for you!
Overview of the position:
- A market leader in In-Vitro Diagnostics are seeking a Regulatory Affairs Senior Director, who will be focused on developing, communicating, and executing Regulatory strategic initiatives with a primary focus on domestic FDA regulations.
- Responsible for supporting FDA quality system regulations such as 21CFR 801, 803, 806, 820, 21 CFR 1270 and 1271, ISO 13485, IVDR, CAMDCAS as well as any relevant international guidelines.
- Provides direction and oversight on external regulatory projects
- Strategic development and intelligence for in vitro diagnostic (IVD) and external diagnostic business and partnering activities.
Skills / Abilities / Competencies
- Minimum of 10 years Regulatory Affairs in diagnostic FDA submissions experience required.
- BA/BS degree or equivalent. Advanced degree a plus. Bachelor's Degree in Business, Sciences, Engineering, Business Development, or related field requiring strategic and analytical thinking.
- Provide critical strategic and tactical IVD/CDx regulatory mentorship that positively influences project planning & decision-making.
- Handle interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), investigational device exemption (IDE)) submissions.
- Experience with the FDA in creating, submitting, and gaining approval on diagnostic products through 510(k) clearance, as well as premarket approval (PMA). Companion diagnostic (CDx) submission experience a significant plus.
- Develop regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies.
- Provide regulatory input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Development teams.
- Review key regulatory submissions to Center for Devices and Radiological (CDRH) (as cooperated with diagnostic partners) and corresponding therapeutic dossiers.
- Assessing impact of relevant drug and IVD/CDx regulations on drug and IVD/CDx development & registration activities, respectively.
- Practical knowledge of varied regulatory requirements and quality practices (i.e., 21CFR820. ISO 13485, AABB, 212 CFR 1270 & 1271, IVD, IVDD/IVDR and CE marking experience)
- Interact with international regulatory colleagues and diagnostic partners to resolve standard methodologies and least burdensome regulatory paths towards development and global registration activities.
- Builds bridges across geographical, cultural and functional boundaries to enhance collaboration, including the strong interpersonal skills to successfully perform in a complex global matrix environment.
- Demonstrated track record for results, leadership and change management. A proven history of driving significant change in a short period of time in a positive and non-disruptive manner.
- Executive presence including confidence, performing well under pressure and decisiveness
- Drives effective collaborations with General Managers, Business Development, Medical Affairs, Clinical Affairs and Scientific Communications to ensure patient needs and clinical trial objectives are a shared focus leading to scientifically robust and compliant strategies and diagnostic product approvals.
- Develop and lead strategic regulatory initiatives to support growth of the company’s diverse businesses and portfolio.
- Demonstrates ability to maintain excellent positive relationships with regulators and auditors as needed.
- Is accountable for the performance and results of the FDA related Regulatory organization, including registrations, submissions, supporting clinicals, talent & organizational development, and departmental objectives.
- Develops strategies and plans to meet performance objectives of the organization.
- Manage timelines, budgets and resource allocation according to requirements of the business.