Associate Director Regulatory Affairs - Global Regulatory Services
Associate Director Regulatory Affairs - Global Regulatory Services
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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.
In Abbotts Global Regulatory Services (GRS) division were helping people to have access our life-changing technologies and products by providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports.
The Opportunity
The Associate Director Regulatory Affairs will work for our Global Regulatory Services division within Leveraged Services. As an Associate Director the individual is to combine knowledge of scientific regulatory and business issues to enable products that are developed manufactured or distributed to meet required legislation. This new team member will support key digital health technology activities (i.e. software cybersecurity telehealth digital solutions etc.) and be recognized as an expert and resource within the division. The individual should have a strong understanding of the software lifecycle management and software development including design validation and maintenance in the device regulatory environment. Demonstrates ability to interpret and apply regulatory requirements to software systems including documentation risk management and compliance strategies. Assists management and leadership on regulatory activities and works with the medical device business units that Leverage Services team supports including the execution of strategic regulatory initiatives regulatory submissions agency relationship and evaluation of regulatory policies. The individual will apply strong communication skills strategic thinking and leadership experience to support the medical device business units with their regulatory submissions. Collaborates closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements drawing on sound knowledge of medical device regulations and experience such as from the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). This Associate Director Regulatory Affairs may analyze broad scope implications of changing regulations guidance or regulatory shifts. Additionally may identify data needed obtain this data and ensure that the information is effectively shared across the medical device businesses.
What Youll Work On
- Review regulatory submissions involving software components (e.g. 510(k) PMAs CE marking technical files).
- Collaborate closely with internal regulatory colleagues to ensure project strategies and regulatory submissions meet global requirements
- Develops regulatory strategies with the medical device business units for new products or changing existing products especially with FDA
- Supports and provide critical review of key documents necessary for regulatory submissions for new products or changes to existing products.
- Ensure that regulatory submissions that contain digital health technologies (i.e. software cybersecurity telehealth etc.) have targeted mitigations to align with FDA expectations ensuring high-quality submissions and predictability for approval
- Assists BU RA at team meetings and applies influence and negotiation skills to resolve issues
- Works with BU RA to resolve deficiencies that may have received for submissions
- Maintains awareness of regulatory legislation regulations and guidances.
- Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA
- Utilizes technical regulatory skills to proposed strategies on complex issues
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and update leadership
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Provide strategic input and technical guidance on regulatory requirements to development teams as requested
- Identify and present option for risk mitigation to decision makers
- Support regulatory trackers for submissions to identify areas for new or continued training in order to implement appropriate regulatory strategies to mitigate risks
- Provide summary of key issues related to submissions at a high level to leadership
- Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
- Evaluate proposed preclinical clinical and manufacturing changes for regulatory filing strategies.
Required Qualifications
- Bachelors degree
- Minimum 5 - 7 years experience in a regulated industry.
- Effectively communicate verbally and in writing prepare and negotiate both internally and externally with various regulatory agencies.
Preferred Qualifications
- Bachelors degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields.
- M.S. in a technical area or MBA. A Ph.D. in a technical area or law is helpful.
- At least 5 years experience in regulatory affairs; highly preferred with medical devices.
- At least 5 years working directly with the FDA on medical devices
- Knowledge on PMAs IDEs 510(k)s: Past experience in strategic thinking planning preparing or reviewing and demonstrated experience with US submissions and a solid knowledge of FDA regulations
- Strong understanding of software lifecycle management including design validation and maintenance in regulated environments.
- In-depth knowledge of regulatory frameworks (e.g. FDA EMA ISO 13485 GDPR) relevant to software products especially in healthcare and medical devices.
- Ability to interpret and apply regulatory requirements to software systems including documentation risk management and compliance strategies.
- Familiarity with cybersecurity and data privacy regulations as they pertain to software products
- Experience managing projects planning and conducting meetings and leading teams to ensure completion of project tasks
- Previous experience with 510k / PMA /IDEs / Q-submissions.
- Must be able to juggle multiple and competing priorities.
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ability to problem solve while being detailed oriented is critical
- Has a sound knowledge of a variety of alternatives and their impact on the business.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
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
$146700.00 $293300.00In 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 > Minnesota > Plymouth : 5050 Nathan Lane N United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza United States > Texas > Plano : 6600 Pinecrest
WORK SHIFT:
Standard
TRAVEL:
Yes 15 % 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:
Exec
Employment Type
Full-Time
Key Skills
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