Do you have the proven ability to collaborate, inspire and work across the entire organization to develop world class global regulatory strategy for combination products and specialty balloons? Are you passionate about developing regulatory strategy with internal cross functional teams assessing new product capabilities and being our guide and messenger to convey the plan across the organization?
If your answer is yes, then we may be looking for you!
Spectranetics is on the search for a Director of Regulatory Affairs – Drug Coated and Specialty Balloons
What You Will Do: You will lead the global development of our combination products and specialty balloons with other program leadership across multiple facilities. You will be a key leader in shaping our future through regulatory strategies and developing a team of regulatory experts.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with an incredible team of dedicated experts and leaders who will be developing the next standard of care for Peripheral and Coronary procedures. Our leaders are focused on supporting your continued growth. We will expand your capabilities to help further our organization's ability to innovate, manufacture, acquire, and commercialize medical devices for Vascular Intervention and Cardiovascular procedures.
What You Will Become: A successful leader and expert in the entire continuum regulatory approval, and an influential teammate who will continue to drive us in our mission and values as we save and improve patient lives. You will become an advocate to help us stay at the forefront of safety and innovation regarding our high-quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
- Preparing global regulatory strategies for new devices and manufacturing processes. Clearly communicates strategies throughout the business.
- Overseeing the preparation of global regulatory filings for new products, as well as product and manufacturing changes.
- Supporting the regulatory team in providing regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Professionally negotiate with government entities (e.g. FDA, notified bodies, etc.)
- Following Spectranetics Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD, PMDA, CMDR and all other applicable regulations.
- Maintaining proficiency in worldwide regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
- Ensures appropriate training of Regulatory Affairs staff takes place.
- Manages the regulatory team by providing guidance and support on daily operations and submissions.
- Manage the regulatory team by providing guidance and support on daily operations and submissions
- Bachelor's or Master's degree in Engineering or Science
- Strong success running teams
- 10 years of experience in applicable domestic/international submissions, design control systems and/or regulatory compliance
- 4+ years of experience with medical device regulatory submissions
- 4+ years dual device experience
- Demonstrated and extensive experience in major regulatory filings, e.g. Original PMA, IDE, Design Dossier
- Working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions
- It is imperative that candidates for consideration have direct Regulatory experience in working with or at the FDA on combination product related IDE and PMA submissions
- Excellent oral communication and technical writing skills
Material and Equipment Directly Used:
- Knowledge of PC hardware/software, documentation and archives
The individual filling this position must be able to:
- lift and carry items weighing over 30 pounds
- submit to a background and employment verification as required
- submit to the required health checks-ups on an annual basis or as required
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.