Manager of Regulatory Affairs (Americas)

Santa Clara Valley, CA, USA | Apple

  • Industry:
    Information Technologies
  • Position Type:
    Full-Time
  • Functions:
    Regulatory Affairs
  • Experience:
    10-12 years
Job Description:
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10+ years of medical device experience in a regulatory role, with at least 5+ years as a principal or manager

Significant experience in leading interactions with regulatory health authorities

Preparing global product submissions required including STED, CDST and other global templates.

Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices

Strong knowledge of global regulations

Description

You will lead a team of Regulatory Affairs associated and represent the Regulatory team on a diverse array of regulatory initiatives and new product development programs, with the goal of marketing new technologies. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You’ll also be responsible for establishing a team culture and process for executing the above tasks in creative ways that still meets regulatory and legal frameworks.

Education & Experience

B.S. degree or equivalent in a lifescience, legal or business discipline

M.S/ PhD/ post-secondary education preferred

Additional Requirements

- Executive poise and presence, including a track record of positively influencing decisions and teams

- Advanced knowledge of management techniques and practices including day-to-day management and establishing a team culture

- Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.

- Working as part of a focused project team

- Proven competence in determination of appropriate global regulatory requirements for new products or product changes.

- Partnering with and across engineering teams to set regulatory strategy

- Strong organizational and management skills.

- Excellent communication skills, both verbal and written