Senior Regulatory Operations Specialist – Digital Health Technologies (on-site)
Abbott
- Alameda, CA
- $83,600-167,200 per year
- Permanent
- Full-time
- Career development with an international company where you can grow the career you dream of
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the
- 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
- As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
- 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 digital products worldwide.
- The individual may prepare documentation needed for registration worldwide or may oversee such preparation.
- Provide regulatory input to digital product lifecycle planning.
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
- Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
- Determine trade issues to anticipate regulatory obstacles.
- Determine and communicate submission and approval requirements.
- Participate in risk-benefit analysis for regulatory compliance.
- Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
- Compile, prepare and review regulatory submission to authorities.
- Monitor impact of changing regulations on submission strategies.
- Monitor applications under regulatory review.
- Monitor and submit applicable reports to regulatory authorities.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Negotiate and interact with regulatory stakeholders during the development and review process to ensure submission approval.
- Assist compliance with product post-marketing approval requirements.
- Assess external communications relative to regulations.
- Review regulatory aspects of contracts.
- Assist with label development and review for compliance before release.
- Submit and review change controls to determine the level of change and consequent submission requirements.
- Analyze the input of cumulative product changes to current product submissions.
- Contribute to the development and functioning of the crisis/ issue management program.
- Ensure product safety issues and product associated events are reported to regulatory agencies.
- Provide regulatory input for product recalls and recall communications.
- Bachelor’s degree (or equivalent);
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
- Knowledge of principles and requirements of applicable product laws
- Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs)
- Domestic and international regulatory guidelines, policies and regulations
- Ethical guidelines of the regulatory profession, clinical research and regulatory process
- Pay strong attention to detail, manage projects and create project plans and timelines.
- Think analytically, organized and track complex information.
- Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business. Use in-depth knowledge of business functions and cross group dependencies/ relationships
- Define regulatory strategy with supervision
- Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Advanced degree in Engineering, Sciences, or related discipline
- Ability to work effectively on cross-functional teams
- Strong written, verbal and presentation skills
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Alameda : 2901 Harbor Bay ParkwayADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: NoSIGNIFICANT 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