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Premarket Regulatory Specialist / Senior Specialist

  • Permanent
  • Anywhere

Website Applied Medical

Applied Medical

Company : Applied Medical

Country: United States

Location : Rancho Santa Margarita, California

Post: Sat, 30 Jul 2022 21:43:00 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

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Applied Medical is a rapidly growing new generation medical device company with a proven business model and commitment to innovation. Developing and manufacturing advanced surgical technologies for over 30 years, Applied Medical has earned a strong reputation in healthcare as being dedicated to delivering the highest quality products and meeting customer needs.

 

The Regulatory Affairs team plays a critical role in all phases of the device lifecycle, including design and configuration, development, approval, and post-market surveillance. The team applies creativity and critical thinking to market implementation and regulatory submission strategies which enables Applied Medical’s devices to make a meaningful, positive difference in more than 80 countries.

 

Pursuing a positive, growth-driven environment, leaders at Applied Medical prioritize team member development. Management on the Regulatory Affairs team identify and create opportunities for team members to professionally grow and cultivate.

We kindly ask that you submit a cover letter explaining your career interests in addition to your resume and application. Depending on your level of experience, this posting is for a Specialist or Senior Specialist role.

Position Description:
As Premarket Regulatory Affairs (Senior) Specialist, you will be responsible for being a self-starter and working in a collaborative environment to perform the duties listed below.

Understand the design, manufacturing process and clinical application of one of our medical devices

Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions and decision making

Monitor the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents

Manage regulatory submissions and communicate with regulatory authorities

Collaborate with Engineering, Clinical Development and other departments in the design and development process of our medical devices and ensure regulatory requirements are met in the markets where devices are distributed

Contribute to regulatory strategy planning and change management in US and European Union markets

Review and approve design history and risk management file documentation (e.g., design inputs and outputs, hazard analyses, clinical evaluation reports) and product labeling

Review and approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions

Participate in audits and inspections by regulatory agencies

Mentor team members throughout the organization through subject matter expertise and experience

Propose, initiate and drive business process improvement projects

Position Requirements:
This position requires the following skills and attributes:

Minimum 2 years (Specialist) or 5 years (Senior Specialist) of experience in Regulatory Affairs or Quality Assurance in the medical device industry

Minimum 1 year of active experience applying design controls

Experience in reviewing and approving technical documentation

Technical background in engineering, or biological or physical sciences

Experience effectively managing projects and developing advanced organizational skills

Ability to multitask and prioritize projects that align with departmental and organizational objectives

Working knowledge of domestic and international regulations, standards and guidance documents

Strong writing, verbal and interpersonal communication skills

Ability to work independently and as part of a team

Assertive and not afraid to ask questions

Strategic-minded, analytical and detail-oriented

As a healthcare company, it is of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We require all new team members to be fully vaccinated (including booster shots, if eligible) upon their start date at Applied Medical (legitimate accommodation requests will be considered). Our current team members have also made this commitment to being vaccinated and receiving the booster shot to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic. Eligibility details to receive the COVID-19 booster shot are provided on the CDC website .

Preferred:
The following skills and attributes are preferred:

Training in quality systems including QSR, ISO and CE marking, usability, and human factors

Experience with mechanical and electrical medical devices 

Benefits:
Training and mentorship with ongoing learning and development courses

On-campus wellness activities

Comprehensive medical and dental and vision coverage

Education reimbursement program

401(k) program with discretionary employer match

Generous vacation accrual and paid vacation schedule

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

To apply for this job please visit www.resume-library.com.