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Sr. Principal Regulatory Affairs Specialist

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Location
MN
Job Type
Direct Hire
Date
Jan 11, 2019
Job ID
2650264
Our mid-sized medical device client is building their regulatory department and have recently launched over 18 new products into the market with additional products this year! They have brought on new senior leadership and implementing a 3-year global quality and regulatory improvement program. This is a ground floor opportunity to write new submissions, remediation and new MDR work. The regulatory leadership team is creating a fun, possitive environment!

The Sr. Principal RA Specialist will prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.

Your role with the company:

• A recognized leader and authority in regulatory. Performs advanced regulatory work requiring recognized expertise in all aspects of regulation, guidance, standards and compliance expectations. Explores and recommends innovative, creative and complex technology for use in companies product development and market authorization support. Applies advanced theories, concepts, principles, and processes in assigned area of responsibility. Devises new approaches to non-routine problems as encountered.
• Oversees regulatory submission strategy development and activities of major significance, which are highly difficult and complex in nature.
• Work requires the expert application of advanced and innovative regulatory strategies for support of global market authorizations.
• Establishes and maintain relationships with key individuals and contributors within the regulatory governing community and specifically within agencies in markets we participate in.
• Responsible for ensuring the right frequency of communications within and outside of department in support of regulatory activities, such as project management meetings, project review, etc.
• Drives the decision-making process, conducts meetings, and makes presentations for assigned projects. Oversees the preparation of documentation associated with regulatory submissions including 510(k)s, annual reports, Technical Files and Design Dossiers.
• Provides strategic leadership, technical advice and direction to other members of the regulatory team.
• No direct subordinates; provides functional supervision to the regulatory team and acts as a recognized leader and authority in the regulatory area.
• Provides innovative approaches to problem resolution. Represents company with customer groups and technical forums such as MDMA and MedTech Europe.
• Develops and conducts facilitated training and development programs for internal departments designed to increase knowledge in issues related to regulatory.
• Provides technical leadership on major programs and provides guidance and direction to the regulatory team. Sets goals/deadlines and adhering to them, holding teams accountable for meeting deadlines to drive results.
• Plans and assigns work to the regulatory team (tasks and responsibilities; assists in the evaluation of personnel performance).
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company
documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Desired Profile:

• Scientific University Degree (BS degree) required
• 18+ years of experience, with an advanced degree strongly preferred. 
• Proven ability to lead, establish, maintain and influence effective working relationships with internal customers within the region and across functions.
• Ability to handle multiple priorities and to meet key deadlines under pressure through effective time management skills.
• Ability to critically review and interpret technical documentation.
• Ability to work accurately with attention to detail.
• Ability to clearly convey ideas and concepts verbally and in writing.
• Ability to coach and mentor others in technical matters.
• Ability and willingness to lead and create change - changes in policy, procedure, technology and culture.