Regulatory Affairs Specialist

This is a mid-level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. The role supports the Regulatory Affairs team by communicating regulatory strategies and preparing essential documentation for market authorizations. Additionally the position involves maintaining regulatory information systems. Strong communication and technical writing skills are essential to succeed in this role.

Participate in multidisciplinary teams and communicate regulatory requirements effectively
Provide regulatory input to product lifecycle planning
Obtain and evaluate the regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices
Conduct appropriate research to develop strong regulatory strategies for new products
Determine issues that may create regulatory obstacles and investigate solutions
Prepare and submit applicable regulatory documentation as required (with focus on the US EU and Canadian markets) and/or compile necessary documentation as requested by International Regulatory Affairs personnel
Monitor progress of submission reviews and interact with regulatory agencies as appropriate
Participate in risk management assessments
Review and approve product labeling advertising and promotional information for regulatory compliance
Assist with SOP development and implementation
Maintain regulatory information systems
Support device import/export and distribution control activities
Support regulatory compliance initiatives
Monitor the impact of changing and evolving global regulations on submissions practices and procedures and communicate to appropriate personnel
Other duties as assigned by the Regulatory Affairs management team
Adhere to and ensure the compliance of Teleflexs Code of Ethics all Company policies rules procedures and housekeeping standards

Associate or Bachelors degree preferably in the science or engineering disciplines
Must have 2-5 years in a medical device organization preferably in regulatory affairs
Previous US Canadian and EU submissions experience preferred
RAC certification preferred
Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills
Proficient in Microsoft Office Suite

Must be a well-organized self-starter who takes the initiative for independent work with attention to detail and has the ability to follow written and verbal instructions.
Manage assigned projects and related activities propose market authorization strategies effectively participate on cross-functional teams and identify and solve mid-level problems.
Must possess a basic understanding of product risk/benefit concepts working knowledge of US and International regulations applicable to market authorization for Vascular products good verbal communication technical writing intra- and interdepartmental communication and collaboration skills.

INDIVIDUAL CONTRIBUTORS:
Commitment to Goals A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks staying focused on priorities and consistently delivering high-quality work. Being proactive managing time effectively and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives individual contributors play a vital role in driving results and advancing shared goals.

Continuous Improvement Continuous improvement means actively seeking ways to enhance your work skills and contributions. Its critical to stay curious embrace feedback and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take the initiative to learn from experiences adapt to change and apply new knowledge to drive better outcomes. By consistently striving to improve they add value to their team and support the organizations growth and success.

Culture and Values Living our culture and values is essential to fostering a positive collaborative work environment. Individual contributors demonstrate this by treating others with respect acting with integrity and contributing to an inclusive and supportive team culture. Its critical to hold oneself accountable align actions with shared values and support the broader mission of the organization. By consistently modeling these behaviors individual contributors help strengthen the workplace culture and positively influence those around them.

The pay range for this position at commencement of employment is expected to be between $88000.00 - $130000.00; however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position will also include benefits such as medical prescription drug dental and vision insurance flexible spending accounts participation in 401(k) savings plan and various paid time off benefits such as PTO short- and long-term disability and parental leave dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired the employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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