Senior Regulatory Affairs Specialist

REPORTS TO: VP, Quality and Regulatory Affairs

DESCRIPTION

The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.

JOB RESPONSIBILITIES

  • Adheres to Viant Core Beliefs including all safety and quality requirements.
  • Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Provides strategic input to Product Development teams, offering a high level of experience in regulatory strategy, timelines, and direction.
  • Authors US and International submissions and works with government agencies and/or distributors to obtain product approvals and clearances.
  • Develops and maintains Technical Documentation in compliance with MDD 93/42/EEC and SOR/98-282.
  • Creates and reviews product labelling that complies with all US and International regulatory requirements.
  • Reviews product changes and assess regulatory impact to US and International regulatory strategy and submissions per standard procedures.
  • Evaluates post-market surveillance plans and reports.
  • Assists with site inspections by external parties (FDA, ISO, MDSAP).
  • Develops and maintains regulatory processes and procedures in compliance with 21 CFR Part 820.
  • Performs other functions as required.

The successful candidate will

  • Manage a high volume of activities with frequently changing priorities.
  • Identify potential regulatory roadblocks and provide innovative strategies for resolution.
  • Provide regulatory guidance through the interpretation of regulations, policies and guidelines.
  • Display strong written and oral communication skills.
  • Operate with a high level of  honesty, integrity and professionalism.
  • Demonstrate a commitment to quality excellence and continuous improvement.

REQUIREMENTS

Education/Certification

Bachelor’s degree in a related field.

Experience

7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience.

Skills/Competencies

Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers. Ability to work through difficult issues with suppliers and customers.

Travel

Less than 10% domestic

Equipment Used

n/a

Physical Requirements

  • Light work: Exerting up to 10 pounds of force occasionally, and/or up to 5 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
  • Motor coordination: Dexterity.

Visual Acuity

  • Close vision

Work Conditions

  • Worker is not exposed to adverse environmental conditions.

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.