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Principal Regulatory Affairs Specialist

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
Michigan (USA), United States

Offer summary

Qualifications:

Bachelor of Science or related advanced degree., Minimum of 9 years in FDA regulated industry., Experience authoring regulatory submissions. , Strong knowledge of medical device regulations..

Key responsabilities:

  • Develop regulatory strategies for medical devices.
  • Interact with regulatory authorities and monitor submission reviews.
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Job description

Job Title: Principal Regulatory Affairs Specialist

Job Location: Portage, MI, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.

The Principal Regulatory Affairs Specialist will support Software heavy devices as well as be a technical and cultural leader for the IVS Regulatory Affairs team and the Instruments RA department. You will need to understand, and be able to explain regulatory strategy for more complex devices as the product portfolios expand; and a person with a principal level knowledge and understanding is needed to support.

We are currently seeking a Principal Regulatory Affairs Specialist to join our Instruments Division. This is a Hybrid or Remote role with in office expectations, to be based in Portage, Michigan. Candidates that reside on the East Coast will be given preference.

What You Will Do

  • Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products, intended for higher class medical devices which may include, but are not limited to IDEs, serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy).
  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes, product claims/labeling.
  • Determines requirements (local, regional, global) and options for regulatory submission, approval pathways, and compliance activities.
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • 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 of Science, engineering or related Advanced degree
  • A minimum of 9 years of working in an FDA regulated industry required.
  • Previous experience authoring 510(k)s and other regulatory submissions required.
  • Experience interacting with regulatory agencies required.
  • Strong leadership skills.
  • Demonstrated success in management of global regulatory strategy and submission activities required.
  • Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).
  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
  • Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
  • Strong interpersonal, written and oral communication skills.
  • Good time and project management skills with the ability to multi-task.

Preferred

  • MS in Regulatory Science
  • RAC (Regulatory Affairs Certification)

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.


Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/befe95274423549a993632434a7648af

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Information Technology & Services
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Adaptability
  • Communication
  • Leadership
  • Time Management

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