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Director, Regulatory Affairs

Company: Philips International
Location: Plymouth
Posted on: September 12, 2020

Job Description:

In this role, you have the opportunity to

Lead one of the Regulatory Affairs groups within the Device group of the Image Guided Therapy Business Unit within Philips. You will be leading individual contributors, generally operating at a more senior level, establishing team development plans and clear communication processes are key, formulating the medium term regulatory policy for his/ her sub discipline and processes results into a regulatory strategic plan, while also being involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations. You’ll also establish work plans and delegate assignments to your team, work on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives and implements regulatory strategy when selecting methods, techniques, and evaluation criteria for obtaining results. Finally, you’ll regularly interact with senior management on matters concerning several functional areas and/or customers.

You are responsible for

Developing a team of specialists responsible for all laser and mechanical tools within IGT.

Driving improvement in regulatory aspects of the Quality System, developing processes and detailing procedures to ensure an effective Quality System.

Reviewing and recommending changes for design process and manufacturing procedures to maintain quality and regulatory compliance

Providing mentorship on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.

Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.

Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.

Advising on regulatory policy (for market release) in line with Philips regulatory policy;

Representing Philips in an international committee chartered to develop an applicable standard.

Your Team

At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To succeed in this role, you should have the following skills and experience

8+ years of experience in a medically regulated and technical environment with at least 5+ years in a medical device company (FDA Class III).

3+ years of people management; direct & indirect.

Experience with successful preparation and submission of Technical File, Design Dossiers, 510(k), PMA, and international documents or registration.

Knowledgeable of MDD and MDR, ISO13485, IDE and 510(k) premarket notification.

Excellent knowledge of regulations (21CFR), FDA law and CE marking

Experience in supporting international registrations.

4+ years preparing, reviewing, and filing U.S. medical device regulatory submissions, including 510(k)s, PMAs, and Q-submission filings

BS Degree in science (biology, biochemistry, chemistry, microbiology, immunology, pharmacology), engineering, medical-related or health-related field preferred

Regulatory Affairs Certification (US) through RAPS preferred

Experience efficiently securing a number of FDA clearances and approvals

Strong working knowledge of FDA regulations, including knowledge of medical device development process and related FDA regulations across full product life cycle

Experience with ISO 14155 and other clinical regulatory requirements is a plus

Strong attention to detail and well-developed analytical thinking skills

Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met

Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objective

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223 , option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

LI-PH1

Contact If you forgot your password, you can click the  Forgot Password button on the Sign In screen to reset it.

If you have any other questions regarding the recruitment process please refer to our FAQs . In case of technical  difficulties with the website,  please send an email  to  careersite@philips.com .

(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox . Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did.

Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team.

We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while transforming themselves personally and professionally.

Working at Philips is more than a job . It’s an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members , marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

Keywords: Philips International, Plymouth , Director, Regulatory Affairs, Other , Plymouth, Massachusetts

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