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Senior Regulatory Affairs Specialist

2 months ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

The Senior Regulatory Affairs Specialist is responsible for generating worldwide product approval submission activities for the company in accordance with all applicable regulations. This position plays a key role in the success of the organization's ability to obtain market clearances and approvals for all products. The position is responsible for the preparation of domestic and international regulatory submissions to support the company’s regulatory strategies.

  • Represent Regulatory on project teams and partner with project team to ensure alignment of global regulatory strategy with the team objectives
  • Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions
  • Write, review, and file regulatory submissions to ensure devices are commercially available in the assigned market(s) based on the approved regulatory strategy
  • Communicate with regulatory agencies on administrative and routine matters
  • Document, consolidate, and maintain verbal and written communication with the regulatory agencies
  • Review change order documents and ascertain impact on current regulatory approvals
  • Review promotional material and labeling for regulatory compliance
  • Develop and maintain regulatory files and records
  • Support and contribute into developing, editing, or revising regulatory processes
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
  • Consistently promotes collaboration, positivity, accountability, and resourcefulness.
  • Must demonstrate mutual respect, ongoing communication and a positive outlook with both internal team members and customers.

Education:

Minimum Bachelor's degree in a related discipline; or equivalent combination of education and experience.


Required Experience:

  • 7-10 years of professional regulatory/quality experience in the medical device, pharmaceutical/ biotechnology industry or regulatory agency.
  • Must have several years of domestic and international clinical and regulatory experience including Class II & III device experience.
  • Effective written communication specific to medical device regulatory submissions.
  • Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field.
  • Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed.
  • Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes.
  • Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others. Must be able to read, write and speak effectively.
  • Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork, and remain flexible and open-minded. Able to quickly adapt to change.
  • Capable of following realistic plans, goal setting, resource management, contingency planning, coordinating, and cooperating with others.
  • Capable of working thoughtfully under pressure and in a timely manner.