Principal Regulatory Affairs Specialist â Vascular (on-site)
Principal Regulatory Affairs Specialist â Vascular (on-site)
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$ 85300 - 170700
1 Vacancy
Job Description
JOB DESCRIPTION:
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree
- A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity working mothers female executives and scientists
The Opportunity
We are seeking a Principal Regulatory Affairs Specialist to join Abbotts Vascular Division on-site in St. Paul MN. Abbott Vascular provides innovative minimally invasive and cost-effective products for the treatment of vascular disease.
As an experienced individual contributor a Principal Regulatory Affairs Specialist is to provide support for the regulatory department ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses evaluation preparation and submission of documentation for the worldwide regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
What Youll Work On
- Develops worldwide strategies for regulatory approval of new and modified products.
- Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. Coordinates compiles and submits regulatory submissions including IDE European Dossiers Premarket Notifications PMA Supplements Change Notifications and other country-specific product registrations.
- Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.
- Maintains annual licenses registrations and listing information. Assists with compliance to product post-marketing approval requirements.
- Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
- Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies ensuring that communications are relevant specific and convey all necessary detail.
- Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate team members.
- Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
- Interfaces directly with regulatory agencies as needed.
- Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
- Communicates with and maintains productive constructive relationships with external customers as required regulatory authorities Notified Bodies in-country affiliates and/or distributors.
- Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
- Complies with US Food and Drug Administration (FDA) and international regulations 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
- Bachelors Degree in Scientific discipline e.g. Chemistry life Sciences Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820 ISO 13485 the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
PreferredQualifications
- Minimum of 5 years experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus.
- Experience with either IDE applications 510(k) applications PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
- Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
- Experience with word processing spreadsheet and presentation graphic software packages.
- Experience working in a broader enterprise/cross-division business unit model.
- 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.
- Ability to identify solve problems and work independently with little oversight.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills as well as attention to detail.
- Ability to maintain regular and predictable attendance.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$85300.00 $170700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
AVD Vascular
LOCATION:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW
ADDITIONAL LOCATIONS:
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: EEO is the Law link - Espanol: Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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