Regulatory Compliance Engineer

Regulatory Compliance Engineer

Regulatory Compliance Engineer Job Description:

The Engenious Regulatory Compliance Engineer is a collaborative people-person who provides product leadership in the design of new medical devices. This position is an expert in translating standards into product requirements drawing on experience in medical device development, product safety and EMC compliance. A key expert who helps get life-saving medical devices to market – that are safe and effective.

Responsibilities:

  • Provide expert-level guidance on the application of IEC 60601-1 family standards, FDA guidance and international market requirements, with emphasis on electrical safety, EMC, and mechanical safety.
  • Apply standards knowledge to complex medical devices to ensure compliance.
  • Create, review, and manage to standards-compliant plans in areas such as risk management, software, human factors, test and development.
  • Craft concise engineering and technical rationales for use in regulatory submissions.
  • Guide, review and participate in risk management activities for product development.
  • Provide subject matter expertise and collaborate with multi-discipline design teams including electrical, mechanical, software, test, human factors, manufacturing and quality engineers.
  • Document isolation diagrams, construction diagrams, critical component lists, essential performance and other safety or compliance-related items.
  • Direct and participate in the evaluation, review and testing of medical devices, including accurate interpretation of test setups specified within standards and documentation of results.
  • Trainer and teacher, able to educate engineers on the application of standards, consulting to answer questions or troubleshoot issues in collaboration with engineering teammates.
  • Key liaison between clients and safety agencies through evaluation processes, expediting timely approval.

Team Expectations:

  • Maintain professional relationships, communication, demeanor, appearance and work environment.
  • Work for the collective good, giving others the benefit of the doubt.
  • Act and speak to support rather than inhibit or sabotage others (clients, teammates, external partners).
  • Work collaboratively with a sense of urgency, ownership and attention to detail.
  • Internally driven for productivity.
  • Maintain a healthy work/life balance.
  • Makes it happen, not just there when it happens.
  • Able to think on her/his feet.
  • Self-aware, others-aware, situationally aware.
  • Humble, but self-confident.
  • Adjust focus on detail or a broader view to suit the situation.
  • Be conversant about the medical device industry, advanced technology product development processes, and medical concepts including anatomy, physiology, and disease processes relevant to medical device work.
  • Work within schedule and budget constraints making appropriate trade-off decisions.
  • Must be authorized to work in the U.S.

Benefits Summary:

Everyone matters at Engenious and we take a holistic approach to benefits because we believe that every aspect of our work matters. It should go without saying (but we’re saying it anyway!) that our full-time employees and their families get comprehensive healthcare (including health, vision and dental), life insurance, paid vacation/personal days/sick days, FMLA leave, paid maternity/paternity/adoption leave, profit sharing, HSA with employer match, mobile phone stipend, and more.

We encourage employees to collaborate and suggest expected and unexpected ways to continually improve benefits. Our benefits rival, and even exceed, those of large organizations – we’ve got your back.

Our Team Is Marked By These Four Cultural Aspirations

Relate

We invest in healthy relationships with our team, clients, suppliers, partners, and our community.

Create

We create new things that improve lives.

Produce

We work quickly to get what’s important done.

Improve

We have healthy unrest with the status quo, and we take responsibility to make things better.

Have Questions? Feel free to email us at work@engenio.us

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