Medical Device Regulatory Affairs Development (RAD) Program

Regulatory Jobs; Santa Clara (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

HIP PPO medical plan

Excellent retirement savings plan

Tuition reimbursement

Free U education benefit

Job summary

Abbott is offering a Medical Device Regulatory Affairs Development (RAD) program with three 1-year rotations across regulatory submissions, documentation, and operations. Positions will be based in Alameda, Pleasanton, Santa Clara, CA, with additional sites in MN and TX.

Rotations may involve regulatory activities and global database maintenance. Candidates should have a life sciences or engineering background, strong communication skills, and adaptability to a matrixed work environment.

Qualifications

• Strong communication and written skills across levels in the organization.
• Ability to work in a matrixed, global environment.
• Ability to multitask and meet deadlines in a fast-paced setting.
• Familiarity with regulatory guidelines and FDA/global standards.

Responsibilities

• Assist in preparing regulatory applications and annual reports.
• Review and approve engineering changes.
• Act as regulatory representative on guidelines analysis.
• Review communications for regulatory compliance and completeness.
• Maintain up-to-date domestic and international medical device regulations.
• Support product release through licensing and approvals.
• Interface with FDA and other agencies as needed.
• Support QMS, EMS, and other regulatory requirements.

Skills

Strong communication

Teamwork

Attention to detail

Regulatory knowledge

Education

Bachelor's degree in life sciences or engineering

Job description

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

We currently have several opportunities for the Medical Device Regulatory Affairs Development (RAD) Program to be located in Alameda, Pleasanton, and Santa Clara, CA, Minneapolis, MN or Plano, TX. This position performs three 1-year rotations that include specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Additionally, during certain rotational periods the position may be responsible for regulatory operations activities such as logistics management of global product release, and maintaining tools needed for managing global regulatory business such as the regulatory database and global regulatory SharePoint sites.

What You’ll Work On

• Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• May interface directly with FDA and other regulatory agencies if so directed.
• Reviews protocols and reports to support regulatory submissions.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.
• Ability to move to various US locations based on rotational assignment

Preferred Qualifications

• BA or BS degree in life sciences (i.e., chemistry, biology, etc.) or engineering (i.e., biomedical, mechanical, chemical, etc.). Recent graduates highly preferred.
• Some experience with medical device industry.
• Experience working in a broader enterprise/cross-division business unit model.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is

$73,900.00 – $116,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

MD Medical Devices

LOCATION:

United States > Santa Clara : Building A - SC

ADDITIONAL LOCATIONS:

United States > Alameda : 2901 Harbor Bay Parkway, United States > Minnesota > Plymouth : 5050 Nathan Lane N, United States > Pleasanton : 6101 Stoneridge Dr, United States > Sylmar : 15900 Valley View Court, United States > Texas > Plano : 6901 Preston Road

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf