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Job Details

Senior Regulatory Affairs Specialist

Company name
Stryker.

Location
Helena, MT, United States

Employment Type
Full-Time

Industry
Compliance, Engineering, Sciences

Posted on
Jun 19,2019

Valid Through
Oct 02,2019

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Profile

Who we want

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

The Senior Regulatory Affairs Specialist works to bring medical devices to market and ensures ongoing compliance. Participates on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes.

Responsibilities:

Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature

Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance

Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

Evaluates proposed products for regulatory classification and jurisdiction

Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes

Negotiates with regulatory authorities throughout the product lifecycle

Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

Assists other departments in the development of SOPs to ensure regulatory compliance

Provides regulatory input and technical guidance on global regulatory requirements to product development teams

Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

Provides regulatory information and guidance for proposed product claims/labeling

Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

Monitors the progress of the regulatory authority review process through appropriate communications with the agency

Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

Bachelor’s degree required; Engineering, Science or related

MS in Regulatory Science preferred

MS and/or RAC desired

3 years of related experience required

Experience drafting 510(k)s preferred

Work From Home: Yes

Travel Percentage: Up to 25%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com

Company info

Stryker.
Website : http://www.stryker.com

Company Profile
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

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