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Regulatory Affairs Manager
Putting a new spin on your career
Working at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don’t simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!
Responsible for the management of US regional regulatory activities for assigned development and commercially marketed products in the US. The major roles and responsibilities of this position are: Responsibility for corporate liaison with FDA and other national regulatory agencies as appropriate; Responsible for the development, content and submission of complete and quality regulatory filings; Responsible for the provision and execution of effective and optimal regional regulatory strategies; Management, development and mentoring of assigned regulatory staff. Key accountabilities include developing effective professional relationships with regulatory agencies to ensure a positive company image, as well as providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of products. Ensuring compliance with national regulatory standards and commitments.
Essential Duties and Responsibilities:
- Ensures alignment of regulatory strategy development related to all product lines for government submissions and support incorporating the strategies via the franchise regulatory leads into product development plans to ensure rapid and timely approval on new and modifications to existing medical devices/combination products.
- Act as site contact for all Regulatory questions.
- Actively participate in establishing business short- and long-range strategic business goals and direct implementation activities to achieve goals.
- Coaches and functions as a local go-to person for the on-site regulatory team and ensure alignment of the level of quality of regulatory deliverables. Functions as conduit between the regulatory team and the team manager.
- Reviews regulatory submission documents (IDE, PMA, 510(k), TF) to assure a uniform quality document which meets company and government requirements.
- Develop a process that establishes the CSI requirements for the quality of submission documents, authorities responses etc. in partnership with key stakeholders in regulatory, quality and clinical.
- Manage and author comments on regulations, guidance and standard documents with potential to impact the business and directs a proactive posture for compliance. Maintains awareness of all changes/developments in regulatory laws as they are applicable to CSI product and report to Regulatory Management.
- Establish and administer education and training of relevant CSI employees on current and emerging regulatory and related requirements.
- Establish and maintain a regulatory document management tool (regulatory communication, meeting reports).
- Create a program for pro-active annual reporting for selected product lines (outside the existing regulatory requirements) based on historical requests from authorities (such as TGA, MHRA) and on market, media and company development or risk.
- Manage project staffing across multiple submissions and clients.
- Manage personnel including hiring, training, and conducting performance reviews.
- Creates development plans and mentor subordinates to reach these developmental objectives.
- 4 Year / Bachelor Degree
- 10+ year’s related experience in being involved in drug, medical device, or equivalent.
- Minimum of 5 years experience managing teams of 5 or more employee
- Ten years broad-based direct experience with regulatory submissions to FDA (510(k), IDE, PMAA), with successful track record of implementation; as company champion and liaison with government agencies, standards committees towards assuring a proactive business posture and compliance; and customer focus
- Experience working on and coaching cross-functional teams required, multi-disciplinary experience including marketing is preferred.
- Ten years minimum international submission preparation experience.
- Five years minimum development and five years interpretation/application experience with standards, guidelines and regulatory requirements.
- Capable of managing multiple projects and complex timelines in a team environment
- Excellent interpersonal, communication, analytical and organizational skills. Good negotiation skills essential.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Excellent staff management skills, ability to lead, train and mentor staff at all levels
- Ability to work in a highly matrix working environment is important given the need to interact effectively with other GRA functions, internal departments and external organizations.
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.
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Job posted: 2022-04-24