Director, Regulatory Affairs
- Colorado Springs, CO
Director, Regulatory Affairs
In this role, you have the opportunity to
Lead one of the Regulatory Affairs groups within the Device group of the Image Guided Therapy Business Unit within Philips. You will be leading individual contributors, generally operating at a more senior level, establishing team development plans and clear communication processes are key, formulating the medium term regulatory policy for his/ her sub discipline and processes results into a regulatory strategic plan, while also being involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations. You'll also establish work plans and delegate assignments to your team, work on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives and implements regulatory strategy when selecting methods, techniques, and evaluation criteria for obtaining results. Finally, you'll regularly interact with senior management on matters concerning several functional areas and/or customers.
You are responsible for
- Developing a team of specialists responsible for all laser and mechanical tools within IGT.
- Driving improvement in regulatory aspects of the Quality System, developing processes and detailing procedures to ensure an effective Quality System.
- Reviewing and recommending changes for design process and manufacturing procedures to maintain quality and regulatory compliance
- Providing mentorship on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA's guidance documents etc.
- Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
- Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
- Advising on regulatory policy (for market release) in line with Philips regulatory policy;
- Representing Philips in an international committee chartered to develop an applicable standard.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- 8+ years of experience in a medically regulated and technical environment with at least 5+ years in a medical device company (FDA Class III).
- 3+ years of people management; direct & indirect.
- Experience with successful preparation and submission of Technical File, Design Dossiers, 510(k), PMA, and international documents or registration.
- Knowledgeable of MDD and MDR, ISO13485, IDE and 510(k) premarket notification.
- Excellent knowledge of regulations (21CFR), FDA law and CE marking
- Experience in supporting international registrations.
- 4+ years preparing, reviewing, and filing U.S. medical device regulatory submissions, including 510(k)s, PMAs, and Q-submission filings
- BS Degree in science (biology, biochemistry, chemistry, microbiology, immunology, pharmacology), engineering, medical-related or health-related field preferred
- Regulatory Affairs Certification (US) through RAPS preferred
- Experience efficiently securing a number of FDA clearances and approvals
- Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle
- Experience with ISO 14155 and other clinical regulatory requirements is a plus
- Strong attention to detail and well-developed analytical thinking skills
- Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met
- Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objective
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
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