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Manager Regulatory Affairs-CMC Devices

Lexington, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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Opportunity

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Manager Regulatory Affairs-CMC Devices

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Job ID SR0045245 Date posted 01/06/2020 Location Lexington, Massachusetts

Primary Role:

Under the direction of the Head of Device Regulatory Affairs, the incumbent direct and manage medical device Regulatory Affairs activities for developing global CMC medical device and IVD strategies across product life cycles & execution for global products. Provide collaborative support for execution of global strategies to other regions (EU, LATAM, APAC, etc.). Manage submissions and interactions with the FDA, Notified Bodies, and Health Canada for device development issues supporting either stand-alone medical devices or combination products. Provide support to other Health Authority (HA) interactions as required.

Provide regulatory support, guidance and expertise to internal groups such as product life cycle development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.

Manage preparation of regulatory filings in a timely manner to meet corporate objectives. Responsible for US, EU and OUS Regulatory Affairs for multiple medical device product lines filed as under 510(k), and EU Technical Files for medical devices and/or device content sections in a combination product.

Collaborate with international regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.

Interact as device lead with project teams and representative for device regulatory with health regulatory agencies.

Responsibilities:
30%:
Lead the preparation and filing of 510k, Technical Files and or CMC sections of regulatory submissions and interactions with regulatory agencies.

25%:
Develop global device regulatory strategy for one or more investigational and marketed products. Support and handle device labeling activities such as device packaging, labeling and IFU development.

20%:
Manage regulatory assessment and guidance on product compliance topics including life cycle development, change controls, deviations, and GMP investigations.

15%:
Collaborate with EU & International regulatory colleagues in development of global medical device regulatory strategies.

10%:
Review and approve technical documentation including technology transfer protocols, design validation, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.

Education & Experience Requirements:

  • Bachelor’s degree in science or engineering related pharmaceutical or medical device field.
  • Masters in Regulatory Affairs strongly preferred.
  • Minimum of 5-7 years of related experience within a pharmaceutical/medical device company, CRO or similar organization and with minimum of 3 years International/Global regulatory experience in medical device and companion diagnostics development and registration activities.


About Shire:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.


Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0045245

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