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Senior Regulatory Affairs Specialist in Portage, MI at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

The Senior Regulatory Affairs Specialist supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as regulatory team resource.

General Responsibilities:

  • Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work
  • Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Project management, writing, coordination, and execution of regulatory items
  • Completing technical and scientific regulatory assignments that are broad in nature

Tasks may include: 

  • Assisting in SOP development and review
  • Assisting in the development and update of regulatory strategy based upon regulatory changes
  • Providing regulatory input new product development and product lifecycle planning
  • Evaluating regulatory impact of proposed changes to launched products
  • Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
  • Determining and communicating submission and approval requirements
  • Participating in risk-benefit analysis for regulatory compliance
  • Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions

Additional tasks may include:

  • Maintaining annual licenses, registrations, and listings
  • Reviewing regulatory aspects of contracts
  • Ensuring compliance with product post-approval or clearance requirements
  • Approving labeling, advertising and promotional items for compliance before release
  • Reviewing publicly disseminated information to minimize regulatory exposure
  • Reviewing product claims and preserving confidentiality of applicable product information
  • Providing regulatory input for and appropriate follow-up to inspections and audits
  • Assisting in the development and implementation of SOPs and systems to track and manage product-associated events
  • Reviewing change management to determine the level of change and potential submission requirements
  • Identifying product-associated problems and developing proposals for solutions
  • Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
  • Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
  • Monitoring impact of changing regulations on submission strategies
  • Identifying issues early in the submission preparation process that could impact product launch
  • Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
  • Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance

Expected areas of competence:

  • Knowledge of the Quality System Regulations (21 CFR)
  • Knowledge of the Medical Device Directives (MDD) and MEDDEV guidance
  • Knowledge of other regulations related to Pre Market Clearance and Post Market Support
  • Ability to understand and explain detailed regulatory compliance programs and/or issues
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
  • Ability to identify and correct errors and inconsistencies (e.g. grammatical, contextual, etc.).
  • Ability to communicate and network with regulatory personnel to obtain relevant information
  • Ability to work with cross functional teams
  • Ability to plan and conduct meetings
  • Ability to negotiate internally and externally with FDA, NB and other regulatory bodies

Qualifications/work experience preferred:

  • Excellent analytical and writing skills
  • Effective interpersonal communication skills
  • Effective organizational skills
  • Advanced PC skills
  • Previous experience in legal, technical or a regulated environment
  • 1-3 years Regulatory Affairs experience in the medical device or pharmaceutical industry

Education/Special Training Required:

  • B.S. or B.A. in Engineering, Life Sciences or equivalent required
  • RAC certification (preferred)

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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